A comparative clinical study of short-term results of laparoscopic surgery for rectal cancer during the learning curve (original) (raw)

Laparoscopic Resection in Rectal Cancer Patients: Outcome and Cost-Benefit Analysis

Diseases of The Colon & Rectum, 2007

Purpose This study was designed to evaluate the impact of laparoscopic rectal resection on short-term postoperative morbidity and costs. Methods A total of 168 patients with rectal cancer were randomly assigned to laparoscopic (n = 83) or open (n = 85) resection. Outcome parameters were: postoperative morbidity, length of hospital stay, quality of life, long-term survival, and local recurrences. The mean follow-up period was 53.6 months. Cost-benefit analysis was based on hospital costs. Results Operative time was 53 minutes longer in the laparoscopic group (P < 0.0001). Postoperative morbidity rate was 28.9 percent in the laparoscopic vs. 40 percent in the open group (P = 0.18). The mean length of hospital stay was 10 (4.9) days in the laparoscopic group and 13.6 (10) days in the open group (P = 0.004). Local recurrence rate and five-year survival were similar in both groups; however, the limited number of patients does not allow firm conclusions. Quality of life was better in the laparoscopic group only in the first year after surgery (P < 0.0001). The additional charge in the laparoscopic group was 1,748perpatientrandomized(1,748 per patient randomized (1,748perpatientrandomized(1,194 the result of surgical instruments and 554theresultoflongeroperativetime).Thesavinginthelaparoscopicgroupwas554 the result of longer operative time). The saving in the laparoscopic group was 554theresultoflongeroperativetime).Thesavinginthelaparoscopicgroupwas1,396 per patient randomized ($647 the result of shorter length of hospital stay and 749theresultofthelowercostofpostoperativecomplications).Thenetbalanceresultedin749 the result of the lower cost of postoperative complications). The net balance resulted in 749theresultofthelowercostofpostoperativecomplications).Thenetbalanceresultedin351 extra cost per patient randomly allocated to the laparoscopic group. Conclusions Short-term postoperative morbidity was similar in the two groups. Laparoscopic resection reduced length of hospital stay, improved first-year quality of life, and slightly increased hospital costs.

Effects of Surgical Laparoscopic Experience on the Short-term Postoperative Outcome of Rectal Cancer

Surgical Laparoscopy, Endoscopy & Percutaneous Techniques, 2010

Purpose: The purpose of the study was to assess the effects of the surgeon's learning curve on the short-term outcome of laparoscopic resections performed for rectal cancer. Methods: A total of 284 patients who underwent laparoscopic resection for rectal cancer performed by 3 different surgical teams between 2005 and 2008 were included in the study. The operative experience was represented by the team's previous surgical case numbers (frequency). Four skill levels were categorized as follows: Level 1: the first 60 cases, Level 2: 61 to 120 cases, Level 3: 121 to 180 cases, and Level 4:>180 cases. Characteristics of the patients, perioperative variables, and the experience levels of the surgeons were analyzed and compared. To investigate the learning curve, we used the following parameters: duration of operative time, conversion rates, general complications, anastomotic leak rates, and oncologic parameters. Results: Operative time gradually decreased with increasing experience. The mean operative times for Level 1, Level 2, and Level 3 were 195.0±46.7, 181.7±34.2, and 172.3±33.0 minutes, respectively, whereas the mean operative time for Level 4 was 151.3±27.7 minutes (P<0.05). With increased experience, conversion rates, complication rates, anastomotic leak rates, and hospitalization durations decreased (P<0.05). The resected specimen length was found to be longer with increased surgical experience (P<0.05). There were no significant differences among the groups with regard to tumor size, T stage, harvested lymph node count, lateral margin involvement, and R0 resections. Conclusions: The operative time is inversely proportional to the level of skill. Laparoscopic surgical procedures do not have any negative effects on short-term surgical outcome. With the strict application of surgical principles, the oncologic quality of the specimen is not influenced by the experience period. With increased experience, the surgeon feels more confident and performs more difficult and complex laparoscopic surgical interventions for rectal cancer.

Laparoscopic Colon Resection Early in the Learning Curve: What Is the Appropriate Setting

Annals of Surgery, 2006

Introduction: Laparoscopic colon resection (LCR) is a safe and effective treatment of benign and malignant colonic lesions. There is little question that a steep learning curve exists for surgeons to become skilled and proficient at LCR. Because of this steep learning curve, debate exists regarding the appropriate hospital setting for LCR. We hypothesize that outcomes of LCR performed early in the learning curve at a regional medical center (New Hanover Regional Medical Center; NHRMC) and a university medical center (Baylor College of Medicine; BCM) would not be significantly different. Methods: The first 50 consecutive LCRs performed at each institution between August 2001 and December 2003 were reviewed. Age, mean body mass index (BMI), gender, history of previous abdominal surgery (PAS), operative approach ͓laparoscopic (LAP) versus hand/laparoscopic assisted (HAL)͔, conversions (Conv), operative time (OR time), pathology (benign vs. malignant), lymph nodes (LN) harvested in malignant cases, length of stay (LOS), morbidity and mortality were obtained. Continuous data were expressed as mean Ϯ SD. Data were analyzed by 2 , Fisher exact test, or t test. Results: NHRMC patients were on average older females with a higher incidence of PAS. A LAP approach was more frequently performed at BCM (86%), whereas HAL was used more frequently at NHRMC (24%). Conversions to open were similar at both institutions (12%). Benign disease accounted for the majority of operations at both institutions. In cases of malignancy, more LN were harvested at BCM. OR time and LOS were shorter at NHRMC. Complication rates were similar between institutions. There were no anastomotic leaks or deaths. Conclusions: LCR can be performed safely and with acceptable outcomes early in the learning curve at regional medical centers and university medical centers. Outcomes depend more on surgeons possessing advanced laparoscopic skills and adhering to accepted oncologic surgical principles in cases of malignancy, than on the size or location of the healthcare institution.

Laparoscopic Colon Resection Early in the Learning Curve

Annals of Surgery, 2006

Introduction: Laparoscopic colon resection (LCR) is a safe and effective treatment of benign and malignant colonic lesions. There is little question that a steep learning curve exists for surgeons to become skilled and proficient at LCR. Because of this steep learning curve, debate exists regarding the appropriate hospital setting for LCR. We hypothesize that outcomes of LCR performed early in the learning curve at a regional medical center (New Hanover Regional Medical Center; NHRMC) and a university medical center (Baylor College of Medicine; BCM) would not be significantly different. Methods: The first 50 consecutive LCRs performed at each institution between August 2001 and December 2003 were reviewed. Age, mean body mass index (BMI), gender, history of previous abdominal surgery (PAS), operative approach ͓laparoscopic (LAP) versus hand/laparoscopic assisted (HAL)͔, conversions (Conv), operative time (OR time), pathology (benign vs. malignant), lymph nodes (LN) harvested in malignant cases, length of stay (LOS), morbidity and mortality were obtained. Continuous data were expressed as mean Ϯ SD. Data were analyzed by 2 , Fisher exact test, or t test. Results: NHRMC patients were on average older females with a higher incidence of PAS. A LAP approach was more frequently performed at BCM (86%), whereas HAL was used more frequently at NHRMC (24%). Conversions to open were similar at both institutions (12%). Benign disease accounted for the majority of operations at both institutions. In cases of malignancy, more LN were harvested at BCM. OR time and LOS were shorter at NHRMC. Complication rates were similar between institutions. There were no anastomotic leaks or deaths. Conclusions: LCR can be performed safely and with acceptable outcomes early in the learning curve at regional medical centers and university medical centers. Outcomes depend more on surgeons possessing advanced laparoscopic skills and adhering to accepted oncologic surgical principles in cases of malignancy, than on the size or location of the healthcare institution.

Laparoscopy in the surgical treatment of rectal cancer in Germany 2000-2009

Colorectal Disease, 2012

Aim The goal of this registry study was to compare open surgery with planned laparoscopy and then with laparoscopic to open conversion for rectal cancer surgery. Method The study included 17 964 rectal cancer patients, operated on between 1 January 2000 and 31 December 2009, from 345 hospitals in Germany. All statistical tests were two-sided, with the v 2 test (Pearson correlation) for patients and tumour characteristics. Fisher's exact test was used for complications and 30-day mortality. Results Of the 17 964 rectal cancer patients, 16 308 (90.8%) had an open procedure and 1656 (9.2%) were started with a laparoscopy. The 1455 patients with completed laparoscopic operations had fewer intra-operative and postoperative complications (5.4% vs 7.0%, P = 0.020, and 20.5% vs 25.8%, P < 0.001, respectively) and a lower 30-day mortality rate (1.1% vs 1.9%, P = 0.023). Of the 1656 planned laparoscopies, 201 (12.1%) were converted to open. The converted group suffered more intra-operative complications (18.9% vs 3.6% for completed laparoscopy and 7.0% for open surgery, P < 0.0001) and postoperative complications (32.3% vs 18.9% for completed laparoscopy and 25.8% for open operations, P < 0.0001). The converted group also had a higher 30-day mortality rate (2.0% vs 1.0% for completed laparoscopy and 1.9% for open surgery, P = 0.043). Conclusion The more favourable patient profile provided justification for a laparoscopic procedure. For those converted to an open procedure, however, there were significantly more complications than planned open surgery patients. A move away from the standard open procedure for rectal cancer surgery and towards laparoscopy is not yet feasible.

Technical difficulty grade score for the laparoscopic approach of rectal cancer

International Journal of Colorectal Disease, 2008

Introduction We aimed to categorize laparoscopic rectal resections according to technical difficulty to standardize learning purposes and stratify results, making future studies more comparable. Materials and methods Fifty patients undergoing a laparoscopic total mesorectal excision were prospectively followed. Four preoperatively known facts (gender, body mass index (BMI), tumor localization, and preoperative radiation therapy) were compared to four operative outcomes (operation time, blood loss, a visual analogue score (VAS) for difficulty rewarded by the surgeon, and oncological radicality of the procedure). Results Operating time for male and female patients was 257 vs. 245 min (P=0.229), blood loss was 300 vs. 300 ml (P=0.309), the VAS was 8 vs. 6 (P<0.001), and radicality was 93% vs. 91% (P=0.806). Operating time was 215, 250, and 305 min for high, mid, and low tumors (Spearman −0.44; P=0.02), respectively. Blood loss was 105, 300, and 600 ml (Spearman −0.38; P=0.01). Lower tumors were rewarded a higher VAS (Spearman −0.57; P<0.001) and

Randomized clinical trial comparing laparoscopic and open surgery in patients with rectal cancer (Br J Surg 2009; 96: 982–989)

British Journal of Surgery, 2010

Sir We would like to thank Mr Renzulli and colleagues, who put their best efforts into this systematic review of atraumatic splenic rupture (ASR). However, a few points need clarification. The authors defined survivors as those who died from underlying disease within 30 days of follow-up or during the hospital stay. Death within 30 days or in hospital means failure of the treatment unless the patient died from an unrelated cause. Those dying in hospital or within 30 days cannot be included in the survivor group as it will not be possible to judge the efficacy of different treatment modalities and this may have a significant impact on the ASR-related mortality. Considering this 30-day criterion, the statistical analysis of ASR-related death cannot be correctly compared with the type of treatment modality. In discussing diagnostic procedures, the authors have not highlighted the sensitivity and specificity of any diagnostic procedures. Ultrasonography was positive for free fluid in 24•6 per cent of patients compared with computed tomography in 23•0 per cent. We think this is a wrong interpretation of the collected data as this suggests that ultrasonography is more sensitive for free fluid. Similarly, peritoneal lavage was positive in 89 patients (10•5 per cent); does this mean that peritoneal lavage done in almost all patients? 1 The data are presented in an ambiguous manner. In the discussion of treatment, the tabulated data do not match the written data. The mortality in the primary non-surgical group (five patients) also needs to be described in detail. Were these deaths in patients who underwent splenectomy because of rebleeding or who completed primary non-surgical treatment?

Laparoscopic versus open surgery for rectal cancer (COLOR II): short-term outcomes of a randomised, phase 3 trial

The Lancet Oncology, 2013

Methods A non-inferiority phase 3 trial was undertaken at 30 centres and hospitals in eight countries. Patients (aged ≥18 years) with rectal cancer within 15 cm from the anal verge without evidence of distant metastases were randomly assigned to either laparoscopic or open surgery in a 2:1 ratio, stratifi ed by centre, location of tumour, and preoperative radiotherapy. The study was not masked. Secondary (short-term) outcomes-including operative fi ndings, complications, mortality, and results at pathological examination-are reported here. Analysis was by modifi ed intention to treat, excluding those patients with post-randomisation exclusion criteria and for whom data were not available. This study is registered with ClinicalTrials.gov, number NCT00297791.

Is laparoscopic rectal surgery really not non- inferior

Mini-invasive Surgery , 2018

Laparoscopic rectal surgery has gained popularity over the last 20 years. Currently there are still questions surrounding the safety and efficacy of this technique as compared to the traditional open modalities. To date, despite the initial enthusiasm for laparoscopic rectal surgery this technique is yet to reach non-inferiority in trials when compared to open resection. This review article discusses the current evidence exploring the value of laparoscopic rectal surgery. It will discuss its evolution over the last 20 years, exploring all the major randomised control trials and their results. It is our belief that laparoscopic rectal surgery for malignancy is not non-inferior to conventional open surgery.