Esther Consten - Academia.edu (original) (raw)
Papers by Esther Consten
Lancet (London, England), Jan 3, 2017
Infected necrotising pancreatitis is a potentially lethal disease and an indication for invasive ... more Infected necrotising pancreatitis is a potentially lethal disease and an indication for invasive intervention. The surgical step-up approach is the standard treatment. A promising alternative is the endoscopic step-up approach. We compared both approaches to see whether the endoscopic step-up approach was superior to the surgical step-up approach in terms of clinical and economic outcomes. In this multicentre, randomised, superiority trial, we recruited adult patients with infected necrotising pancreatitis and an indication for invasive intervention from 19 hospitals in the Netherlands. Patients were randomly assigned to either the endoscopic or the surgical step-up approach. The endoscopic approach consisted of endoscopic ultrasound-guided transluminal drainage followed, if necessary, by endoscopic necrosectomy. The surgical approach consisted of percutaneous catheter drainage followed, if necessary, by video-assisted retroperitoneal debridement. The primary endpoint was a composit...
Gut, Jun 28, 2017
Non-randomised studies suggest that endoscopic mucosal resection (EMR) is equally effective in re... more Non-randomised studies suggest that endoscopic mucosal resection (EMR) is equally effective in removing large rectal adenomas as transanal endoscopic microsurgery (TEM), but EMR might be more cost-effective and safer. This trial compares the clinical outcome and cost-effectiveness of TEM and EMR for large rectal adenomas. Patients with rectal adenomas ≥3 cm, without malignant features, were randomised (1:1) to EMR or TEM, allowing endoscopic removal of residual adenoma at 3 months. Unexpected malignancies were excluded postrandomisation. Primary outcomes were recurrence within 24 months (aiming to demonstrate non-inferiority of EMR, upper limit 10%) and the number of recurrence-free days alive and out of hospital. Two hundred and four patients were treated in 18 university and community hospitals. Twenty-seven (13%) had unexpected cancer and were excluded from further analysis. Overall recurrence rates were 15% after EMR and 11% after TEM; statistical non-inferiority was not reached...
The Lancet, 2015
Case series suggest that laparoscopic peritoneal lavage might be a promising alternative to sigmo... more Case series suggest that laparoscopic peritoneal lavage might be a promising alternative to sigmoidectomy in patients with perforated diverticulitis. We aimed to assess the superiority of laparoscopic lavage compared with sigmoidectomy in patients with purulent perforated diverticulitis, with respect to overall long-term morbidity and mortality. We did a multicentre, parallel-group, randomised, open-label trial in 34 teaching hospitals and eight academic hospitals in Belgium, Italy, and the Netherlands (the Ladies trial). The Ladies trial is split into two groups: the LOLA group comparing laparoscopic lavage with sigmoidectomy and the DIVA group comparing Hartmann's procedure with sigmoidectomy plus primary anastomosis. The DIVA section of this trial is still underway but here we report the results of the LOLA section. Patients with purulent perforated diverticulitis were enrolled for LOLA, excluding patients with faecal peritonitis, aged older than 85 years, with high-dose steroid use (≥20 mg daily), and haemodynamic instability. Patients were randomly assigned (2:1:1; stratified by age [<60 years vs ≥60 years]) using secure online computer randomisation to laparoscopic lavage, Hartmann's procedure, or primary anastomosis in a parallel design after diagnostic laparoscopy. Patients were analysed according to a modified intention-to-treat principle and were followed up after the index operation at least once in the outpatient setting and after sigmoidoscopy and stoma reversal, according to local protocols. The primary endpoint was a composite endpoint of major morbidity and mortality within 12 months. This trial is registered with ClinicalTrials.gov, number NCT01317485. Between July 1, 2010, and Feb 22, 2013, 90 patients were randomly assigned in the LOLA section of the Ladies trial when the study was terminated by the data and safety monitoring board because of an increased event rate in the lavage group. Two patients were excluded for protocol violations. The primary endpoint occurred in 30 (67%) of 45 patients in the lavage group and 25 (60%) of 42 patients in the sigmoidectomy group (odds ratio 1·28, 95% CI 0·54-3·03, p=0·58). By 12 months, four patients had died after lavage and six patients had died after sigmoidectomy (p=0·43). Laparoscopic lavage is not superior to sigmoidectomy for the treatment of purulent perforated diverticulitis. Netherlands Organisation for Health Research and Development.
BMC surgery, Jan 11, 2006
The initial treatment of acute necrotizing pancreatitis is conservative. Intervention is indicate... more The initial treatment of acute necrotizing pancreatitis is conservative. Intervention is indicated in patients with (suspected) infected necrotizing pancreatitis. In the Netherlands, the standard intervention is necrosectomy by laparotomy followed by continuous postoperative lavage (CPL). In recent years several minimally invasive strategies have been introduced. So far, these strategies have never been compared in a randomised controlled trial. The PANTER study (PAncreatitis, Necrosectomy versus sTEp up appRoach) was conceived to yield the evidence needed for a considered policy decision. 88 patients with (suspected) infected necrotizing pancreatitis will be randomly allocated to either group A) minimally invasive 'step-up approach' starting with drainage followed, if necessary, by videoscopic assisted retroperitoneal debridement (VARD) or group B) maximal necrosectomy by laparotomy. Both procedures are followed by CPL. Patients will be recruited from 20 hospitals, includin...
Background: Persisting abdominal complaints are common after an episode of diverticulitis treated... more Background: Persisting abdominal complaints are common after an episode of diverticulitis treated conservatively. Furthermore, some patients develop frequent recurrences. These two groups of patients suffer greatly from their disease, as shown by impaired health related quality of life and increased costs due to multiple specialist consultations, pain medication and productivity losses. Both conservative and operative management of patients with persisting abdominal complaints after an episode of diverticulitis and/or frequently recurring diverticulitis are applied. However, direct comparison by a randomised controlled trial is necessary to determine which is superior in relieving symptoms, optimising health related quality of life, minimising costs and preventing diverticulitis recurrences against acceptable morbidity and mortality associated with surgery or the occurrence of a complicated recurrence after conservative management. We, therefore, constructed a randomised clinical trial comparing these two treatment strategies.
Clinical Microbiology and Infection, 1998
Objective: To investigate and compare the incidence and type of complications related to central ... more Objective: To investigate and compare the incidence and type of complications related to central venous catheters in AIDS patients and in t w o control groups of non-AIDS patients.
British Journal of Surgery, 1995
In patients infected with human immunodeficiency virus (HIV) no effective surgical procedure has ... more In patients infected with human immunodeficiency virus (HIV) no effective surgical procedure has been described for anorectal ulceration that is resistant to medical therapy. This study was designed to determine the effectiveness of surgical excision of anorectal ulcers, with or without mucosal advancement. The medical records of patients with HIV and anorectal pathology diagnosed between 1984 and 1994 were reviewed. Patients with anorectal ulcers were divided into group A which was treated only with excision and group B in which excision was combined with mucosal advancement. Surgical treatment was considered successful if relief of symptoms was achieved within 4 weeks of the operation. Excision of anorectal ulcers was successful in seven of 16 patients (44 per cent) in group A. Relief of symptoms was achieved in 12 of 13 patients (92 per cent) in group B when surgical excision was combined with mucosal advancement, which is significantly better than the results in group A (P = 0.02). This non-randomized study indicates that after unsuccessful medical treatment persistent symptomatic ulcers should be treated operatively by excision with mucosal advancement.
BMC Surgery, 2008
Background: With the availability of infliximab, nowadays recurrent Crohn's disease, defined as d... more Background: With the availability of infliximab, nowadays recurrent Crohn's disease, defined as disease refractory to immunomodulatory agents that has been treated with steroids, is generally treated with infliximab. Infliximab is an effective but expensive treatment and once started it is unclear when therapy can be discontinued. Surgical resection has been the golden standard in recurrent Crohn's disease. Laparoscopic ileocolic resection proved to be safe and is characterized by a quick symptom reduction.
BMC Surgery, 2013
Background: Annually approximately 100.000 patients undergo a laparotomy in the Netherlands. Abou... more Background: Annually approximately 100.000 patients undergo a laparotomy in the Netherlands. About 15,000 of these patients will develop an incisional hernia. Both open and laparoscopic surgical repair have been proven to be safe. However, the most effective treatment of incisional hernias remains unclear. This study, the 'INCH-trial', comparing cost-effectiveness of open and laparoscopic incisional hernia repair, is therefore needed. Methods/Design: A randomized multi-center clinical trial comparing cost-effectiveness of open and laparoscopic repair of incisional hernias. Patients with a symptomatic incisional hernia, eligible for laparoscopic and open incisional hernia repair. Only surgeons, experienced in both open and laparoscopic incisional hernia repair, will participate in the INCH trial. During incisional hernia repair, a mesh is placed under or on top of the fascia, with a minimal overlap of 5 cm. Primary endpoint is length of hospital stay after an incisional hernia repair. Secondary endpoints are time to full recovery within three months after index surgery, post-operative complications, recurrences, mortality and quality of life.
BMC Surgery, 2010
Background: Conservative treatment of uncomplicated or mild diverticulitis usually includes antib... more Background: Conservative treatment of uncomplicated or mild diverticulitis usually includes antibiotic therapy. It is, however, uncertain whether patients with acute diverticulitis indeed benefit from antibiotics. In most guidelines issued by professional organizations antibiotics are considered mandatory in the treatment of mild diverticulitis. This advice lacks evidence and is merely based on experts' opinion. Adverse effects of the use of antibiotics are well known, including allergic reactions, development of bacterial resistance to antibiotics and other side-effects. Methods: A randomized multicenter pragmatic clinical trial comparing two treatment strategies for uncomplicated acute diverticulitis. I) A conservative strategy with antibiotics: hospital admission, supportive measures and at least 48 hours of intravenous antibiotics which subsequently are switched to oral, if tolerated (for a total duration of antibiotic treatment of 10 days). II) A liberal strategy without antibiotics: admission only if needed on clinical grounds, supportive measures only. Patients are eligible for inclusion if they have a diagnosis of acute uncomplicated diverticulitis as demonstrated by radiological imaging. Only patients with stages 1a and 1b according to Hinchey's classification or "mild" diverticulitis according to the Ambrosetti criteria are included. The primary endpoint is time-to-full recovery within a 6-month follow-up period. Full recovery is defined as being discharged from the hospital, with a return to pre-illness activities, and VAS score below 4 without the use of daily pain medication. Secondary endpoints are proportion of patients who develop complicated diverticulitis requiring surgery or non-surgical intervention, morbidity, costs, health-related quality of life, readmission rate and acute diverticulitis recurrence rate. In a non-inferiority design 264 patients are needed in each study arm to detect a difference in time-to-full recovery of 5 days or more with a power of 85% and a confidence level of 95%. With an estimated one percent of patients lost to follow up, a total of 533 patients will be included. Conclusion: A clinically relevant difference of more than 5 days in time-to-full recovery between the two treatment strategies is not expected. The liberal strategy without antibiotics and without the strict requirement for hospital admission is anticipated to be more a more cost-effective approach.
BMC Surgery, 2010
Background: Recently, excellent results are reported on laparoscopic lavage in patients with puru... more Background: Recently, excellent results are reported on laparoscopic lavage in patients with purulent perforated diverticulitis as an alternative for sigmoidectomy and ostomy. The objective of this study is to determine whether LaparOscopic LAvage and drainage is a safe and effective treatment for patients with purulent peritonitis (LOLA-arm) and to determine the optimal resectional strategy in patients with a purulent or faecal peritonitis (DIVA-arm: perforated DIVerticulitis: sigmoidresection with or without Anastomosis). Methods/Design: In this multicentre randomised trial all patients with perforated diverticulitis are included. Upon laparoscopy, patients with purulent peritonitis are treated with laparoscopic lavage and drainage, Hartmann's procedure or sigmoidectomy with primary anastomosis in a ratio of 2:1:1 (LOLA-arm). Patients with faecal peritonitis will be randomised 1:1 between Hartmann's procedure and resection with primary anastomosis (DIVAarm). The primary combined endpoint of the LOLA-arm is major morbidity and mortality. A sample size of 132:66:66 patients will be able to detect a difference in the primary endpoint from 25% in resectional groups compared to 10% in the laparoscopic lavage group (two sided alpha = 5%, power = 90%). Endpoint of the DIVAarm is stoma free survival one year after initial surgery. In this arm 212 patients are needed to significantly demonstrate a difference of 30% (log rank test two sided alpha = 5% and power = 90%) in favour of the patients
The Lancet, 2015
Case series suggest that laparoscopic peritoneal lavage might be a promising alternative to sigmo... more Case series suggest that laparoscopic peritoneal lavage might be a promising alternative to sigmoidectomy in patients with perforated diverticulitis. We aimed to assess the superiority of laparoscopic lavage compared with sigmoidectomy in patients with purulent perforated diverticulitis, with respect to overall long-term morbidity and mortality. We did a multicentre, parallel-group, randomised, open-label trial in 34 teaching hospitals and eight academic hospitals in Belgium, Italy, and the Netherlands (the Ladies trial). The Ladies trial is split into two groups: the LOLA group comparing laparoscopic lavage with sigmoidectomy and the DIVA group comparing Hartmann's procedure with sigmoidectomy plus primary anastomosis. The DIVA section of this trial is still underway but here we report the results of the LOLA section. Patients with purulent perforated diverticulitis were enrolled for LOLA, excluding patients with faecal peritonitis, aged older than 85 years, with high-dose steroid use (≥20 mg daily), and haemodynamic instability. Patients were randomly assigned (2:1:1; stratified by age [<60 years vs ≥60 years]) using secure online computer randomisation to laparoscopic lavage, Hartmann's procedure, or primary anastomosis in a parallel design after diagnostic laparoscopy. Patients were analysed according to a modified intention-to-treat principle and were followed up after the index operation at least once in the outpatient setting and after sigmoidoscopy and stoma reversal, according to local protocols. The primary endpoint was a composite endpoint of major morbidity and mortality within 12 months. This trial is registered with ClinicalTrials.gov, number NCT01317485. Between July 1, 2010, and Feb 22, 2013, 90 patients were randomly assigned in the LOLA section of the Ladies trial when the study was terminated by the data and safety monitoring board because of an increased event rate in the lavage group. Two patients were excluded for protocol violations. The primary endpoint occurred in 30 (67%) of 45 patients in the lavage group and 25 (60%) of 42 patients in the sigmoidectomy group (odds ratio 1·28, 95% CI 0·54-3·03, p=0·58). By 12 months, four patients had died after lavage and six patients had died after sigmoidectomy (p=0·43). Laparoscopic lavage is not superior to sigmoidectomy for the treatment of purulent perforated diverticulitis. Netherlands Organisation for Health Research and Development.
BMC surgery, 2006
The initial treatment of acute necrotizing pancreatitis is conservative. Intervention is indicate... more The initial treatment of acute necrotizing pancreatitis is conservative. Intervention is indicated in patients with (suspected) infected necrotizing pancreatitis. In the Netherlands, the standard intervention is necrosectomy by laparotomy followed by continuous postoperative lavage (CPL). In recent years several minimally invasive strategies have been introduced. So far, these strategies have never been compared in a randomised controlled trial. The PANTER study (PAncreatitis, Necrosectomy versus sTEp up appRoach) was conceived to yield the evidence needed for a considered policy decision. 88 patients with (suspected) infected necrotizing pancreatitis will be randomly allocated to either group A) minimally invasive 'step-up approach' starting with drainage followed, if necessary, by videoscopic assisted retroperitoneal debridement (VARD) or group B) maximal necrosectomy by laparotomy. Both procedures are followed by CPL. Patients will be recruited from 20 hospitals, includin...
Tropical Medicine and International Health, 2000
To quantify the potential impact of simple measures to reduce the risk of iatrogenic HIV infectio... more To quantify the potential impact of simple measures to reduce the risk of iatrogenic HIV infection through blood transfusion in a Zambian district hospital. Three studies were conducted at St. Francis' Hospital, Katete, Zambia: (1) From 1991 to 1995 HIV seroprevalence among all listed blood donors and the impact of proper subgroup selection were studied retrospectively; (2) the sensitivity of locally used rapid antibody assays (HIV-spot/Wellcozyme HIV 1 & 2) for the detection of HIV in donor blood and the influence of the expiration date of the tests on this sensitivity were determined prospectively from June 1993 until March 1994 by screening all consecutive surgical patients and blood donors; (3) the number of unnecessary blood transfusions was determined retrospectively from January 1995 through January 1996 and prospectively from February 1996 through March 1996, and possibilities to reduce the total number of blood transfusions were considered. (1) Excluding prisoners, who have an HIV seroprevalence of 19-25%, from the donor population significantly reduces the overall HIV seroprevalence from 13-16% to 8-9% (P < 0. 01). (2) Under local circumstances the sensitivity of the used rapid antibody assays was 6.8-17.9% lower than claimed by the manufacturer. Usage of non-expired tests increased the sensitivity significantly from 88.2% to 91.7% (P < 0.05). (3) None of the 294 studied blood transfusions can be classified as inappropriate according to international standards. Simple measures such as proper subgroup selection among blood donors and correct use of non-expired tests may decrease the risk of iatrogenic HIV transmission. Stricter indications for blood transfusions will not substantially reduce the number of transfusions.
Transfusion, 1997
The purpose of this study was to estimate the risk of human immunodeficiency virus (HIV) infectio... more The purpose of this study was to estimate the risk of human immunodeficiency virus (HIV) infection via the transfusion of blood tested by inappropriately stored or expired rapid antibody assays in Zambia. Surgical patients (n = 370) were tested with antibody assays (HIV-spot and HIV 1+2) that had expired 3 to 6 months previously. Blood donors (n = 211) were tested by inappropriately stored but non-expired HIV-spot assay. Serum samples from both groups were retested with enzyme immunoassays, and the seropositivity of samples was confirmed by immunoblotting. Seroprevalence in surgical patients and blood donors was 19.8 and 11.6 percent, respectively. Sensitivity and specificity of HIV-spot (expired) were 88.2 and 98.1 percent; those of HIV 1+2 (expired) were 82.1 and 94.7 percent; and those of HIV-spot (non-expired) were 91.7 and 98.8 percent, respectively. The risk of HIV infection via the transfusion of blood tested by HIV-spot (expired), HIV-spot (nonexpired), or HIV 1+2 (expired) was calculated to be 1.4, 1.0, and 3.2 percent, respectively. Manufacturers of the HIV-spot and HIV 1+2 assays claim sensitivity and specificity of 98.8 and 100 percent and 100 and 99.5 percent, respectively. In this study, sensitivity and specificity were 11 to 18 percent lower. Moreover, in-date reagents also performed less well than the manufacturers claimed, but the worst results were with expired or improperly stored reagents. According to the manufacturers of HIV-spot and HIV 1+2, the risk of HIV infection would be 0.2 and 0 percent, respectively. However, the risk of contracting HIV through transfusion is at least six times higher than expected.
Surgical Endoscopy, 2009
The transanal endoscopic operation (TEO) has proved to be an effective alternative to conventiona... more The transanal endoscopic operation (TEO) has proved to be an effective alternative to conventional surgery for the treatment of rectal lesions. The TEO procedure offers reduced morbidity, faster recovery and equivalent oncologic outcome. Currently, two instrument sets are available: one with three-dimensional (Wolf) and one with two-dimensional (Storz) optic capacities. The three-dimensional (3D) instrument set is considered the golden standard. Although the advantages of TEO are imposing, the procedure with the 3D armamentarium has certain technical and financial drawbacks. This study therefore aimed to compare results for the TEO 2D alternative with recently published results for 3D TEO. All consecutive patients with benign or malignant pT1 or pT2 rectal lesions undergoing TEO were prospectively followed. All procedures were performed with the 2D armamentarium using standard endoscopic instruments, a rectoscope (diameter, 4 cm; working length, 7.5-15 cm), and 5-mm Ligasure and Ultracision. Operating times, complications, hospital stay, and oncologic outcome were gathered and compared with published data. Between 2004 and 2006, 31 patients with a median age of 75 years (range, 33-87 years) underwent 31 TEOs for a total of 36 rectal lesions (29 tubulovillous adenomas and 7 adenocarcinomas). The median distance of the lesion from the anal verge was 7.5 cm (range, 5-15 cm). The median lesion diameter was 2.3 cm (range, 0.5-5.0 cm). The locations of the lesions were as follows: 18 on the dorsal, 5 on the ventral, and 5 on the lateral rectal wall. The median operating time was 55 min (range, 25-165 min), compared with 105 min reported in the literature. All the lesions except one could be radically excised. No intraoperative complications occurred. Postoperative complications occurred for three patients, all due to hemorrhage. The median hospital stay was 3 days (range, 1-21 days). During a median follow-up period of 15 months (range, 1-35 months), two recurrences took place. The study findings showed that for rectal tumors located up to 15 cm from the anal verge with a maximal diameter of 5 cm, TEO using standard laparoscopic instruments with a 2D view is feasible and provides results comparable with those associated with a 3D view and dedicated instruments. Furthermore, the 2D procedure can be performed with improved ergonomics due to movable monitors and is considerably less expensive.
Surgical Endoscopy, 2008
Hypothesis Laparoscopic liver surgery is significantly limited by the technical difficulty encoun... more Hypothesis Laparoscopic liver surgery is significantly limited by the technical difficulty encountered during transection of substantial liver parenchyma, with intraoperative bleeding and bile leaks. This study tested whether the use of a bioabsorble staple line reinforcement material would improve outcome during stapled laparoscopic left lateral liver resection in a porcine model. Study design A total of 20 female pigs underwent stapled laparoscopic left lateral liver resection. In group A (n = 10), the stapling devices were buttressed with a bioabsorbable staple line reinforcement material. In group B (n = 10), standard laparoscopic staplers were used. Operative data and perioperative complications were recorded.
Surgery for Obesity and Related Diseases, 2007
Similar to gastric bypass patients, a regimen of ursodeoxycholic acid in the immediate postoperat... more Similar to gastric bypass patients, a regimen of ursodeoxycholic acid in the immediate postoperative period might obviate the need for routine cholecystectomy. Routine cholecystectomy has been recommended for patients who undergo biliopancreatic diversion (BPD), because of the high prevalence of gallstones in the obese patient and presumed development of gallstones postoperatively. We have considered elective cholecystectomy only if gallbladder disease were present. The aim of this study was to assess the need for cholecystectomy in the postoperative period in such patients. In this retrospective study, the data from 219 patients who had undergone BPD with duodenal switch (BPD/DS), from January 1999 to January 2003, were analyzed. We performed a 150-cm alimentary limb and 100-cm common channel BPD/DS. The patients received 600 mg ursodeoxycholic acid orally daily for 6 months. The following data were recorded: demographics, medical history, medication, weight loss, diagnostic evaluation, and operative and pathologic data. Of the 219 patients who underwent surgery, 59 were men (26.9%) and 160 women were (73.1%) (mean age 41.7 years, mean body mass index 55.7 kg/m(2)). The mean follow-up was 30 months (range 12-48). Of the 219 patients, 57 (19.6%) underwent cholecystectomy: 28 (12.7%) preoperatively, 10 (4.5%) simultaneously, and 19 (8.7%) postoperatively. Simultaneous cholecystectomy was performed when the patient had a history of colic episodes with gallbladder disease (disclosed by preoperative ultrasonography). The postoperative cholecystectomy pathology reports showed cholecystitis in only 7 patients. The results of our study have shown that the incidence of postoperative cholecystectomy in BPD/DS patients is low, and cholecystitis is rare. Routine cholecystectomy in BPD/DS patients is no longer recommended.
Journal of Travel Medicine, 2006
Background: Rapid immunochromatographic dipstick assays are used increasingly in many tropical an... more Background: Rapid immunochromatographic dipstick assays are used increasingly in many tropical and Western countries as a tool to diagnose Plasmodium falciparum malaria. However, these tests do not provide any information about the severity of the infection. We evaluated the usefulness of plasma lactate as a parameter for disease severity on admission in imported P. falciparum malaria.
BMC surgery, 2010
Persisting abdominal complaints are common after an episode of diverticulitis treated conservativ... more Persisting abdominal complaints are common after an episode of diverticulitis treated conservatively. Furthermore, some patients develop frequent recurrences. These two groups of patients suffer greatly from their disease, as shown by impaired health related quality of life and increased costs due to multiple specialist consultations, pain medication and productivity losses.Both conservative and operative management of patients with persisting abdominal complaints after an episode of diverticulitis and/or frequently recurring diverticulitis are applied. However, direct comparison by a randomised controlled trial is necessary to determine which is superior in relieving symptoms, optimising health related quality of life, minimising costs and preventing diverticulitis recurrences against acceptable morbidity and mortality associated with surgery or the occurrence of a complicated recurrence after conservative management.We, therefore, constructed a randomised clinical trial comparing ...
Lancet (London, England), Jan 3, 2017
Infected necrotising pancreatitis is a potentially lethal disease and an indication for invasive ... more Infected necrotising pancreatitis is a potentially lethal disease and an indication for invasive intervention. The surgical step-up approach is the standard treatment. A promising alternative is the endoscopic step-up approach. We compared both approaches to see whether the endoscopic step-up approach was superior to the surgical step-up approach in terms of clinical and economic outcomes. In this multicentre, randomised, superiority trial, we recruited adult patients with infected necrotising pancreatitis and an indication for invasive intervention from 19 hospitals in the Netherlands. Patients were randomly assigned to either the endoscopic or the surgical step-up approach. The endoscopic approach consisted of endoscopic ultrasound-guided transluminal drainage followed, if necessary, by endoscopic necrosectomy. The surgical approach consisted of percutaneous catheter drainage followed, if necessary, by video-assisted retroperitoneal debridement. The primary endpoint was a composit...
Gut, Jun 28, 2017
Non-randomised studies suggest that endoscopic mucosal resection (EMR) is equally effective in re... more Non-randomised studies suggest that endoscopic mucosal resection (EMR) is equally effective in removing large rectal adenomas as transanal endoscopic microsurgery (TEM), but EMR might be more cost-effective and safer. This trial compares the clinical outcome and cost-effectiveness of TEM and EMR for large rectal adenomas. Patients with rectal adenomas ≥3 cm, without malignant features, were randomised (1:1) to EMR or TEM, allowing endoscopic removal of residual adenoma at 3 months. Unexpected malignancies were excluded postrandomisation. Primary outcomes were recurrence within 24 months (aiming to demonstrate non-inferiority of EMR, upper limit 10%) and the number of recurrence-free days alive and out of hospital. Two hundred and four patients were treated in 18 university and community hospitals. Twenty-seven (13%) had unexpected cancer and were excluded from further analysis. Overall recurrence rates were 15% after EMR and 11% after TEM; statistical non-inferiority was not reached...
The Lancet, 2015
Case series suggest that laparoscopic peritoneal lavage might be a promising alternative to sigmo... more Case series suggest that laparoscopic peritoneal lavage might be a promising alternative to sigmoidectomy in patients with perforated diverticulitis. We aimed to assess the superiority of laparoscopic lavage compared with sigmoidectomy in patients with purulent perforated diverticulitis, with respect to overall long-term morbidity and mortality. We did a multicentre, parallel-group, randomised, open-label trial in 34 teaching hospitals and eight academic hospitals in Belgium, Italy, and the Netherlands (the Ladies trial). The Ladies trial is split into two groups: the LOLA group comparing laparoscopic lavage with sigmoidectomy and the DIVA group comparing Hartmann's procedure with sigmoidectomy plus primary anastomosis. The DIVA section of this trial is still underway but here we report the results of the LOLA section. Patients with purulent perforated diverticulitis were enrolled for LOLA, excluding patients with faecal peritonitis, aged older than 85 years, with high-dose steroid use (≥20 mg daily), and haemodynamic instability. Patients were randomly assigned (2:1:1; stratified by age [<60 years vs ≥60 years]) using secure online computer randomisation to laparoscopic lavage, Hartmann's procedure, or primary anastomosis in a parallel design after diagnostic laparoscopy. Patients were analysed according to a modified intention-to-treat principle and were followed up after the index operation at least once in the outpatient setting and after sigmoidoscopy and stoma reversal, according to local protocols. The primary endpoint was a composite endpoint of major morbidity and mortality within 12 months. This trial is registered with ClinicalTrials.gov, number NCT01317485. Between July 1, 2010, and Feb 22, 2013, 90 patients were randomly assigned in the LOLA section of the Ladies trial when the study was terminated by the data and safety monitoring board because of an increased event rate in the lavage group. Two patients were excluded for protocol violations. The primary endpoint occurred in 30 (67%) of 45 patients in the lavage group and 25 (60%) of 42 patients in the sigmoidectomy group (odds ratio 1·28, 95% CI 0·54-3·03, p=0·58). By 12 months, four patients had died after lavage and six patients had died after sigmoidectomy (p=0·43). Laparoscopic lavage is not superior to sigmoidectomy for the treatment of purulent perforated diverticulitis. Netherlands Organisation for Health Research and Development.
BMC surgery, Jan 11, 2006
The initial treatment of acute necrotizing pancreatitis is conservative. Intervention is indicate... more The initial treatment of acute necrotizing pancreatitis is conservative. Intervention is indicated in patients with (suspected) infected necrotizing pancreatitis. In the Netherlands, the standard intervention is necrosectomy by laparotomy followed by continuous postoperative lavage (CPL). In recent years several minimally invasive strategies have been introduced. So far, these strategies have never been compared in a randomised controlled trial. The PANTER study (PAncreatitis, Necrosectomy versus sTEp up appRoach) was conceived to yield the evidence needed for a considered policy decision. 88 patients with (suspected) infected necrotizing pancreatitis will be randomly allocated to either group A) minimally invasive 'step-up approach' starting with drainage followed, if necessary, by videoscopic assisted retroperitoneal debridement (VARD) or group B) maximal necrosectomy by laparotomy. Both procedures are followed by CPL. Patients will be recruited from 20 hospitals, includin...
Background: Persisting abdominal complaints are common after an episode of diverticulitis treated... more Background: Persisting abdominal complaints are common after an episode of diverticulitis treated conservatively. Furthermore, some patients develop frequent recurrences. These two groups of patients suffer greatly from their disease, as shown by impaired health related quality of life and increased costs due to multiple specialist consultations, pain medication and productivity losses. Both conservative and operative management of patients with persisting abdominal complaints after an episode of diverticulitis and/or frequently recurring diverticulitis are applied. However, direct comparison by a randomised controlled trial is necessary to determine which is superior in relieving symptoms, optimising health related quality of life, minimising costs and preventing diverticulitis recurrences against acceptable morbidity and mortality associated with surgery or the occurrence of a complicated recurrence after conservative management. We, therefore, constructed a randomised clinical trial comparing these two treatment strategies.
Clinical Microbiology and Infection, 1998
Objective: To investigate and compare the incidence and type of complications related to central ... more Objective: To investigate and compare the incidence and type of complications related to central venous catheters in AIDS patients and in t w o control groups of non-AIDS patients.
British Journal of Surgery, 1995
In patients infected with human immunodeficiency virus (HIV) no effective surgical procedure has ... more In patients infected with human immunodeficiency virus (HIV) no effective surgical procedure has been described for anorectal ulceration that is resistant to medical therapy. This study was designed to determine the effectiveness of surgical excision of anorectal ulcers, with or without mucosal advancement. The medical records of patients with HIV and anorectal pathology diagnosed between 1984 and 1994 were reviewed. Patients with anorectal ulcers were divided into group A which was treated only with excision and group B in which excision was combined with mucosal advancement. Surgical treatment was considered successful if relief of symptoms was achieved within 4 weeks of the operation. Excision of anorectal ulcers was successful in seven of 16 patients (44 per cent) in group A. Relief of symptoms was achieved in 12 of 13 patients (92 per cent) in group B when surgical excision was combined with mucosal advancement, which is significantly better than the results in group A (P = 0.02). This non-randomized study indicates that after unsuccessful medical treatment persistent symptomatic ulcers should be treated operatively by excision with mucosal advancement.
BMC Surgery, 2008
Background: With the availability of infliximab, nowadays recurrent Crohn's disease, defined as d... more Background: With the availability of infliximab, nowadays recurrent Crohn's disease, defined as disease refractory to immunomodulatory agents that has been treated with steroids, is generally treated with infliximab. Infliximab is an effective but expensive treatment and once started it is unclear when therapy can be discontinued. Surgical resection has been the golden standard in recurrent Crohn's disease. Laparoscopic ileocolic resection proved to be safe and is characterized by a quick symptom reduction.
BMC Surgery, 2013
Background: Annually approximately 100.000 patients undergo a laparotomy in the Netherlands. Abou... more Background: Annually approximately 100.000 patients undergo a laparotomy in the Netherlands. About 15,000 of these patients will develop an incisional hernia. Both open and laparoscopic surgical repair have been proven to be safe. However, the most effective treatment of incisional hernias remains unclear. This study, the 'INCH-trial', comparing cost-effectiveness of open and laparoscopic incisional hernia repair, is therefore needed. Methods/Design: A randomized multi-center clinical trial comparing cost-effectiveness of open and laparoscopic repair of incisional hernias. Patients with a symptomatic incisional hernia, eligible for laparoscopic and open incisional hernia repair. Only surgeons, experienced in both open and laparoscopic incisional hernia repair, will participate in the INCH trial. During incisional hernia repair, a mesh is placed under or on top of the fascia, with a minimal overlap of 5 cm. Primary endpoint is length of hospital stay after an incisional hernia repair. Secondary endpoints are time to full recovery within three months after index surgery, post-operative complications, recurrences, mortality and quality of life.
BMC Surgery, 2010
Background: Conservative treatment of uncomplicated or mild diverticulitis usually includes antib... more Background: Conservative treatment of uncomplicated or mild diverticulitis usually includes antibiotic therapy. It is, however, uncertain whether patients with acute diverticulitis indeed benefit from antibiotics. In most guidelines issued by professional organizations antibiotics are considered mandatory in the treatment of mild diverticulitis. This advice lacks evidence and is merely based on experts' opinion. Adverse effects of the use of antibiotics are well known, including allergic reactions, development of bacterial resistance to antibiotics and other side-effects. Methods: A randomized multicenter pragmatic clinical trial comparing two treatment strategies for uncomplicated acute diverticulitis. I) A conservative strategy with antibiotics: hospital admission, supportive measures and at least 48 hours of intravenous antibiotics which subsequently are switched to oral, if tolerated (for a total duration of antibiotic treatment of 10 days). II) A liberal strategy without antibiotics: admission only if needed on clinical grounds, supportive measures only. Patients are eligible for inclusion if they have a diagnosis of acute uncomplicated diverticulitis as demonstrated by radiological imaging. Only patients with stages 1a and 1b according to Hinchey's classification or "mild" diverticulitis according to the Ambrosetti criteria are included. The primary endpoint is time-to-full recovery within a 6-month follow-up period. Full recovery is defined as being discharged from the hospital, with a return to pre-illness activities, and VAS score below 4 without the use of daily pain medication. Secondary endpoints are proportion of patients who develop complicated diverticulitis requiring surgery or non-surgical intervention, morbidity, costs, health-related quality of life, readmission rate and acute diverticulitis recurrence rate. In a non-inferiority design 264 patients are needed in each study arm to detect a difference in time-to-full recovery of 5 days or more with a power of 85% and a confidence level of 95%. With an estimated one percent of patients lost to follow up, a total of 533 patients will be included. Conclusion: A clinically relevant difference of more than 5 days in time-to-full recovery between the two treatment strategies is not expected. The liberal strategy without antibiotics and without the strict requirement for hospital admission is anticipated to be more a more cost-effective approach.
BMC Surgery, 2010
Background: Recently, excellent results are reported on laparoscopic lavage in patients with puru... more Background: Recently, excellent results are reported on laparoscopic lavage in patients with purulent perforated diverticulitis as an alternative for sigmoidectomy and ostomy. The objective of this study is to determine whether LaparOscopic LAvage and drainage is a safe and effective treatment for patients with purulent peritonitis (LOLA-arm) and to determine the optimal resectional strategy in patients with a purulent or faecal peritonitis (DIVA-arm: perforated DIVerticulitis: sigmoidresection with or without Anastomosis). Methods/Design: In this multicentre randomised trial all patients with perforated diverticulitis are included. Upon laparoscopy, patients with purulent peritonitis are treated with laparoscopic lavage and drainage, Hartmann's procedure or sigmoidectomy with primary anastomosis in a ratio of 2:1:1 (LOLA-arm). Patients with faecal peritonitis will be randomised 1:1 between Hartmann's procedure and resection with primary anastomosis (DIVAarm). The primary combined endpoint of the LOLA-arm is major morbidity and mortality. A sample size of 132:66:66 patients will be able to detect a difference in the primary endpoint from 25% in resectional groups compared to 10% in the laparoscopic lavage group (two sided alpha = 5%, power = 90%). Endpoint of the DIVAarm is stoma free survival one year after initial surgery. In this arm 212 patients are needed to significantly demonstrate a difference of 30% (log rank test two sided alpha = 5% and power = 90%) in favour of the patients
The Lancet, 2015
Case series suggest that laparoscopic peritoneal lavage might be a promising alternative to sigmo... more Case series suggest that laparoscopic peritoneal lavage might be a promising alternative to sigmoidectomy in patients with perforated diverticulitis. We aimed to assess the superiority of laparoscopic lavage compared with sigmoidectomy in patients with purulent perforated diverticulitis, with respect to overall long-term morbidity and mortality. We did a multicentre, parallel-group, randomised, open-label trial in 34 teaching hospitals and eight academic hospitals in Belgium, Italy, and the Netherlands (the Ladies trial). The Ladies trial is split into two groups: the LOLA group comparing laparoscopic lavage with sigmoidectomy and the DIVA group comparing Hartmann's procedure with sigmoidectomy plus primary anastomosis. The DIVA section of this trial is still underway but here we report the results of the LOLA section. Patients with purulent perforated diverticulitis were enrolled for LOLA, excluding patients with faecal peritonitis, aged older than 85 years, with high-dose steroid use (≥20 mg daily), and haemodynamic instability. Patients were randomly assigned (2:1:1; stratified by age [<60 years vs ≥60 years]) using secure online computer randomisation to laparoscopic lavage, Hartmann's procedure, or primary anastomosis in a parallel design after diagnostic laparoscopy. Patients were analysed according to a modified intention-to-treat principle and were followed up after the index operation at least once in the outpatient setting and after sigmoidoscopy and stoma reversal, according to local protocols. The primary endpoint was a composite endpoint of major morbidity and mortality within 12 months. This trial is registered with ClinicalTrials.gov, number NCT01317485. Between July 1, 2010, and Feb 22, 2013, 90 patients were randomly assigned in the LOLA section of the Ladies trial when the study was terminated by the data and safety monitoring board because of an increased event rate in the lavage group. Two patients were excluded for protocol violations. The primary endpoint occurred in 30 (67%) of 45 patients in the lavage group and 25 (60%) of 42 patients in the sigmoidectomy group (odds ratio 1·28, 95% CI 0·54-3·03, p=0·58). By 12 months, four patients had died after lavage and six patients had died after sigmoidectomy (p=0·43). Laparoscopic lavage is not superior to sigmoidectomy for the treatment of purulent perforated diverticulitis. Netherlands Organisation for Health Research and Development.
BMC surgery, 2006
The initial treatment of acute necrotizing pancreatitis is conservative. Intervention is indicate... more The initial treatment of acute necrotizing pancreatitis is conservative. Intervention is indicated in patients with (suspected) infected necrotizing pancreatitis. In the Netherlands, the standard intervention is necrosectomy by laparotomy followed by continuous postoperative lavage (CPL). In recent years several minimally invasive strategies have been introduced. So far, these strategies have never been compared in a randomised controlled trial. The PANTER study (PAncreatitis, Necrosectomy versus sTEp up appRoach) was conceived to yield the evidence needed for a considered policy decision. 88 patients with (suspected) infected necrotizing pancreatitis will be randomly allocated to either group A) minimally invasive 'step-up approach' starting with drainage followed, if necessary, by videoscopic assisted retroperitoneal debridement (VARD) or group B) maximal necrosectomy by laparotomy. Both procedures are followed by CPL. Patients will be recruited from 20 hospitals, includin...
Tropical Medicine and International Health, 2000
To quantify the potential impact of simple measures to reduce the risk of iatrogenic HIV infectio... more To quantify the potential impact of simple measures to reduce the risk of iatrogenic HIV infection through blood transfusion in a Zambian district hospital. Three studies were conducted at St. Francis' Hospital, Katete, Zambia: (1) From 1991 to 1995 HIV seroprevalence among all listed blood donors and the impact of proper subgroup selection were studied retrospectively; (2) the sensitivity of locally used rapid antibody assays (HIV-spot/Wellcozyme HIV 1 & 2) for the detection of HIV in donor blood and the influence of the expiration date of the tests on this sensitivity were determined prospectively from June 1993 until March 1994 by screening all consecutive surgical patients and blood donors; (3) the number of unnecessary blood transfusions was determined retrospectively from January 1995 through January 1996 and prospectively from February 1996 through March 1996, and possibilities to reduce the total number of blood transfusions were considered. (1) Excluding prisoners, who have an HIV seroprevalence of 19-25%, from the donor population significantly reduces the overall HIV seroprevalence from 13-16% to 8-9% (P < 0. 01). (2) Under local circumstances the sensitivity of the used rapid antibody assays was 6.8-17.9% lower than claimed by the manufacturer. Usage of non-expired tests increased the sensitivity significantly from 88.2% to 91.7% (P < 0.05). (3) None of the 294 studied blood transfusions can be classified as inappropriate according to international standards. Simple measures such as proper subgroup selection among blood donors and correct use of non-expired tests may decrease the risk of iatrogenic HIV transmission. Stricter indications for blood transfusions will not substantially reduce the number of transfusions.
Transfusion, 1997
The purpose of this study was to estimate the risk of human immunodeficiency virus (HIV) infectio... more The purpose of this study was to estimate the risk of human immunodeficiency virus (HIV) infection via the transfusion of blood tested by inappropriately stored or expired rapid antibody assays in Zambia. Surgical patients (n = 370) were tested with antibody assays (HIV-spot and HIV 1+2) that had expired 3 to 6 months previously. Blood donors (n = 211) were tested by inappropriately stored but non-expired HIV-spot assay. Serum samples from both groups were retested with enzyme immunoassays, and the seropositivity of samples was confirmed by immunoblotting. Seroprevalence in surgical patients and blood donors was 19.8 and 11.6 percent, respectively. Sensitivity and specificity of HIV-spot (expired) were 88.2 and 98.1 percent; those of HIV 1+2 (expired) were 82.1 and 94.7 percent; and those of HIV-spot (non-expired) were 91.7 and 98.8 percent, respectively. The risk of HIV infection via the transfusion of blood tested by HIV-spot (expired), HIV-spot (nonexpired), or HIV 1+2 (expired) was calculated to be 1.4, 1.0, and 3.2 percent, respectively. Manufacturers of the HIV-spot and HIV 1+2 assays claim sensitivity and specificity of 98.8 and 100 percent and 100 and 99.5 percent, respectively. In this study, sensitivity and specificity were 11 to 18 percent lower. Moreover, in-date reagents also performed less well than the manufacturers claimed, but the worst results were with expired or improperly stored reagents. According to the manufacturers of HIV-spot and HIV 1+2, the risk of HIV infection would be 0.2 and 0 percent, respectively. However, the risk of contracting HIV through transfusion is at least six times higher than expected.
Surgical Endoscopy, 2009
The transanal endoscopic operation (TEO) has proved to be an effective alternative to conventiona... more The transanal endoscopic operation (TEO) has proved to be an effective alternative to conventional surgery for the treatment of rectal lesions. The TEO procedure offers reduced morbidity, faster recovery and equivalent oncologic outcome. Currently, two instrument sets are available: one with three-dimensional (Wolf) and one with two-dimensional (Storz) optic capacities. The three-dimensional (3D) instrument set is considered the golden standard. Although the advantages of TEO are imposing, the procedure with the 3D armamentarium has certain technical and financial drawbacks. This study therefore aimed to compare results for the TEO 2D alternative with recently published results for 3D TEO. All consecutive patients with benign or malignant pT1 or pT2 rectal lesions undergoing TEO were prospectively followed. All procedures were performed with the 2D armamentarium using standard endoscopic instruments, a rectoscope (diameter, 4 cm; working length, 7.5-15 cm), and 5-mm Ligasure and Ultracision. Operating times, complications, hospital stay, and oncologic outcome were gathered and compared with published data. Between 2004 and 2006, 31 patients with a median age of 75 years (range, 33-87 years) underwent 31 TEOs for a total of 36 rectal lesions (29 tubulovillous adenomas and 7 adenocarcinomas). The median distance of the lesion from the anal verge was 7.5 cm (range, 5-15 cm). The median lesion diameter was 2.3 cm (range, 0.5-5.0 cm). The locations of the lesions were as follows: 18 on the dorsal, 5 on the ventral, and 5 on the lateral rectal wall. The median operating time was 55 min (range, 25-165 min), compared with 105 min reported in the literature. All the lesions except one could be radically excised. No intraoperative complications occurred. Postoperative complications occurred for three patients, all due to hemorrhage. The median hospital stay was 3 days (range, 1-21 days). During a median follow-up period of 15 months (range, 1-35 months), two recurrences took place. The study findings showed that for rectal tumors located up to 15 cm from the anal verge with a maximal diameter of 5 cm, TEO using standard laparoscopic instruments with a 2D view is feasible and provides results comparable with those associated with a 3D view and dedicated instruments. Furthermore, the 2D procedure can be performed with improved ergonomics due to movable monitors and is considerably less expensive.
Surgical Endoscopy, 2008
Hypothesis Laparoscopic liver surgery is significantly limited by the technical difficulty encoun... more Hypothesis Laparoscopic liver surgery is significantly limited by the technical difficulty encountered during transection of substantial liver parenchyma, with intraoperative bleeding and bile leaks. This study tested whether the use of a bioabsorble staple line reinforcement material would improve outcome during stapled laparoscopic left lateral liver resection in a porcine model. Study design A total of 20 female pigs underwent stapled laparoscopic left lateral liver resection. In group A (n = 10), the stapling devices were buttressed with a bioabsorbable staple line reinforcement material. In group B (n = 10), standard laparoscopic staplers were used. Operative data and perioperative complications were recorded.
Surgery for Obesity and Related Diseases, 2007
Similar to gastric bypass patients, a regimen of ursodeoxycholic acid in the immediate postoperat... more Similar to gastric bypass patients, a regimen of ursodeoxycholic acid in the immediate postoperative period might obviate the need for routine cholecystectomy. Routine cholecystectomy has been recommended for patients who undergo biliopancreatic diversion (BPD), because of the high prevalence of gallstones in the obese patient and presumed development of gallstones postoperatively. We have considered elective cholecystectomy only if gallbladder disease were present. The aim of this study was to assess the need for cholecystectomy in the postoperative period in such patients. In this retrospective study, the data from 219 patients who had undergone BPD with duodenal switch (BPD/DS), from January 1999 to January 2003, were analyzed. We performed a 150-cm alimentary limb and 100-cm common channel BPD/DS. The patients received 600 mg ursodeoxycholic acid orally daily for 6 months. The following data were recorded: demographics, medical history, medication, weight loss, diagnostic evaluation, and operative and pathologic data. Of the 219 patients who underwent surgery, 59 were men (26.9%) and 160 women were (73.1%) (mean age 41.7 years, mean body mass index 55.7 kg/m(2)). The mean follow-up was 30 months (range 12-48). Of the 219 patients, 57 (19.6%) underwent cholecystectomy: 28 (12.7%) preoperatively, 10 (4.5%) simultaneously, and 19 (8.7%) postoperatively. Simultaneous cholecystectomy was performed when the patient had a history of colic episodes with gallbladder disease (disclosed by preoperative ultrasonography). The postoperative cholecystectomy pathology reports showed cholecystitis in only 7 patients. The results of our study have shown that the incidence of postoperative cholecystectomy in BPD/DS patients is low, and cholecystitis is rare. Routine cholecystectomy in BPD/DS patients is no longer recommended.
Journal of Travel Medicine, 2006
Background: Rapid immunochromatographic dipstick assays are used increasingly in many tropical an... more Background: Rapid immunochromatographic dipstick assays are used increasingly in many tropical and Western countries as a tool to diagnose Plasmodium falciparum malaria. However, these tests do not provide any information about the severity of the infection. We evaluated the usefulness of plasma lactate as a parameter for disease severity on admission in imported P. falciparum malaria.
BMC surgery, 2010
Persisting abdominal complaints are common after an episode of diverticulitis treated conservativ... more Persisting abdominal complaints are common after an episode of diverticulitis treated conservatively. Furthermore, some patients develop frequent recurrences. These two groups of patients suffer greatly from their disease, as shown by impaired health related quality of life and increased costs due to multiple specialist consultations, pain medication and productivity losses.Both conservative and operative management of patients with persisting abdominal complaints after an episode of diverticulitis and/or frequently recurring diverticulitis are applied. However, direct comparison by a randomised controlled trial is necessary to determine which is superior in relieving symptoms, optimising health related quality of life, minimising costs and preventing diverticulitis recurrences against acceptable morbidity and mortality associated with surgery or the occurrence of a complicated recurrence after conservative management.We, therefore, constructed a randomised clinical trial comparing ...