BIOLAP: Biological versus synthetic mesh in laparoscopic hernia repair-a randomized multicenter, prospective, self-controlled clinical trial (original) (raw)
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Hernia : the journal of hernias and abdominal wall surgery, 2011
Biologic prostheses are designed to support tissue regeneration rather than just result in a strong scar plate, as is the case with synthetic mesh. It is not known if these newer materials will result in earlier return to normal activities and/or less post-herniorrhaphy groin pain. METHOD/STUDY DESIGN: A prospective, randomized, controlled, third-party-blinded multicenter trial was designed to compare the use of a non-cross linked porcine dermis biologic graft [Strattice(TM) Reconstructive Tissue Matrix (RTM), LifeCell, Branchburg, NJ] versus light weight, large pore polypropylene mesh (UltraPro(TM), Ethicon, Somerville, NJ). The study design called for recruitment of 170 men. These men are being followed for a minimum of 2 years. The primary aim of this study is to compare the safety and effectiveness of the two materials in a Lichtenstein inguinal hernia repair as measured by resumption of activities of daily living. Secondary outcomes include chronic pain, postoperative complicat...
Hernia, 2011
Prosthetic reinforcement is the gold standard treatment for inguinal hernia and reduces the risk of recurrence. Yet up to one-third of patients complain of post-surgical pain due to irritation and inflammation caused by the mesh and the fixation materials. Of these patients, 3-4% will experience severe and disabling chronic pain. We performed a prospective multicenter clinical study of a self-adhering prosthesis, consisting of a lightweight polypropylene mesh (40 g/m²) coated on each side with synthetic glue, to evaluate early postoperative complications and patient outcomes. Between August 2008 and June 2010, 186 patients underwent hernia repair using the Lichtenstein technique and the self-adhering prosthesis. Primary endpoints were the frequency of disabling complications and quality of life (QoL) at 3-month follow-up. Pain, numbness, and groin discomfort were evaluated pre- and postoperatively (1 week, 1 and 3 months) using a visual analogue scale (VAS). Patients' pre- and postoperative QoL were measured using the SF12 questionnaire. Secondary endpoints were number of complications and recurrence rate, use of analgesic drugs, length of hospital stay, delay to return to normal activities, and patient satisfaction. The quality of the self-adhering mesh and its clinical utility were also evaluated by the participating surgeons. A total of 186 patients were enrolled and followed for at least 3 months after inguinal hernia repair. A total of 174 (95%) primary hernias and 12 (5%) recurrent hernias were treated. There were no intraoperative complications, no recurrences, and no repeat interventions performed during the study. The post-surgical complication rate was 4.5%. The mean delay to recover normal physical activity was 4 days. For the primary endpoint of pain, a VAS of zero was reported by 93/184 (50.5%) patients at 1 week, 130/171 (76.0%) patients at 1 month and 119/132 (90.2%) patients at 3 months' follow-up (P < 0.0001). The postoperative SF12 scores showed a significant improvement in patient QoL following surgery (P < 0.0001). Adhesix( ® ) self-adhering mesh for prosthetic reinforcement following inguinal hernia repair is atraumatic and associated with infrequent post-surgical complications or pain, a rapid recovery rate, and a high patient-reported QoL. A longer follow-up is underway to assess the frequency of post-surgical recurrence.
Scientific Reports
With the development of newer meshes and approaches to hernia repair, it is currently difficult to evaluate their performances while considering the patients’ perspective. The aim of the study was to assess the clinical outcomes and quality of life consequences of abdominal hernia repairs performed in Italy using Phasix and Phasix ST meshes through the analysis of real-world data to support the choice of new generation biosynthetic meshes. An observational, prospective, multicentre study was conducted in 10 Italian clinical centres from May 2015 to February 2018 and in 15 Italian clinical centres from March 2018 to May 2019. The evaluation focused on patients with VHWG grade II–III who underwent primary ventral hernia repair or incisional hernia intervention with a follow-up of at least 18 months. Primary endpoints included complications’ rates, and secondary outcomes focused on patient quality of life as measured by the EuroQol questionnaire. Seventy-five patients were analysed. Th...
Comparison of biomaterials: three meshes and TAPP for inguinal hernia
Surgical Endoscopy, 2006
Background: In laparoscopic hernia repair the use of biocompatible materials is necessary. A prospective, double-blind study was projected to compare three different meshes. Methods: Ninety male patients with primary inguinal hernia undergoing transabdominal preperitoneal (TAPP) implant procedures were included. Three different types of mesh were tested: a monofile, heavyweight , rigid mesh (group A), a smooth, heavyweight variant of polypropylene (group B), and a polyglactin/polypropylene compound mesh (group C). Complications, pain development, inability to work, physical conditions, testicular volume, and blood circulation were documented. Results: Convalescence in group A was slower than in groups B and C: Postoperative values of visual scales for pain development were higher, inability to work was 7.3 days longer, urologic effects were more severe, activities of everyday life were more reduced, and data of the German SF-36 Health Survey Test showed a significant reduction of physical condition (p < 0.05). Conclusion: The compound mesh did not create more comfort for the patients than the smooth variant of the heavyweight polypropylene mesh.
Biological meshes for abdominal hernia: Lack of evidence-based recommendations for clinical use
International journal of surgery (London, England), 2018
In the clinical literature on abdominal hernia repair, no sound criteria have been established to support the use of biological meshes as opposed to synthetic ones. Furthermore, the information on biological meshes is quite scarce, and so their place in therapy has not yet been defined. The treatment of primary and incisional ventral hernia was the target intervention evaluated in our analysis. Our study consisted of the following phases: a) Identification of the biologic meshes available on the market; b) Literature search focused on efficacy and safety of these meshes; c) Analysis of the findings derived from the literature search. The information collected this way was reviewed narratively, and presented according to standard meta-analysis. The main end-points of our analysis included infection of surgical wound at 1 month and recurrence at 12 months. Our clinical literature comprised 11 trials that evaluated 5 biological meshes: Permacol (706 patients), Strattice (324 patients),...
Preventing Hernia Recurrence: Optimising Mesh Use in Incisional Hernia Repair
Journal of the Nuffield Department of Surgical Sciences
Incisional hernia is a common complication of abdominal surgery, affecting up to a quarter of patients undergoing laparotomy. This case report discusses a 72-year-old lady with a recurrent incisional hernia following an emergency Hartman’s procedure. The discussion covers the properties of synthetic vs biological meshes, the significance of the anatomical location of the mesh, fixation methods, laparoscopic surgery, short and long term complications. Key points: The ideal mesh is biocompatible, strong, resistant to infection, has minimal bioreactivity and non-immunogenic Pore size is important to the degree of mesh integration, infection risk and the development of chronic pain Synthetic mesh is useful in contaminated cases but adds a significant cost to the procedure Sublay mesh placement is associated with a reduced risk of recurrence Most recurrences occur at the edge of the mesh. Surgeons should ensure a 5cm overlap between the mesh and native tissues and consider dual fixation ...
Mesh versus non-mesh for inguinal and femoral hernia repair
Protocols, 1996
Background This is an update of a Cochrane Review first published in 2001. Hernias are protrusions of all or part of an organ through the body wall that normally contains it. Groin hernias include inguinal (96%) and femoral (4%) hernias, and are often symptomatic with discomfort. They are extremely common, with an estimated lifetime risk in men of 27%. Occasionally they may present as emergencies with complications such as bowel incarceration, obstruction and strangulation. The definitive treatment of all hernias is surgical repair, inguinal hernia repair being one of the most common surgical procedures performed. Mesh (hernioplasty) and the traditional non-mesh repairs (herniorrhaphy) are commonly used, with an increasing preference towards mesh repairs in high-income countries. Objectives To evaluate the benefits and harms of different inguinal and femoral hernia repair techniques in adults, specifically comparing closure with mesh versus without mesh. Outcomes include hernia recurrence, complications (including neurovascular or visceral injury, haematoma, seroma, testicular injury, infection, postoperative pain), mortality, duration of operation, postoperative hospital stay and time to return to activities of daily living. Search methods We searched the following databases on 9 May 2018: Cochrane Colorectal Cancer Group Specialized Register, Cochrane Central Register of Controlled Trials (Issue 1), Ovid MEDLINE (from 1950), Ovid Embase (from 1974) and Web of Science (from 1900). Furthermore, we checked the WHO International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov for trials. We applied no language or publication restrictions. We also searched the reference lists of included trials and review articles. Selection criteria We included randomised controlled trials of mesh compared to non-mesh inguinal or femoral hernia repairs in adults over the age of 18 years. 1 Mesh versus non-mesh for inguinal and femoral hernia repair (Review)
TRENDS OF USING DIFFERENT MESH TYPES FOR HERNIA SURGERY OPERATIONS
International Journal of Medical Reviews and Case Reports, 2024
Background: Hernias are common surgical conditions, and hernioplasty is frequently performed. This review analyzes the efficacy of various nanocoated mesh materials and different ways of mesh fixation in inguinal hernia repair. Methods: A literature search was conducted using PubMed, SCOPUS, and Google Scholar, focusing on studies from January 2018 to January 2024. Results: Meshes coated with polycaprolactone (PCL), graphene oxide (GO), and chitosan (CS) showed improved biocompatibility and antimicrobial properties. Conclusions: Nanocoated meshes, particularly those with GO, CS, and antimicrobials, are recommended for further clinical trials to confirm their benefits in reducing postoperative complications. Also, the best option for mesh fixation is either using the self-gripping meshes or fixation by stapler tacks.
Mesh choice in ventral hernia repair: so many choices, so little time
American journal of surgery, 2013
Currently, >200 meshes are commercially available in the United States. To help guide appropriate mesh selection, the investigators examined the postsurgical experiences of all patients undergoing ventral hernia repair at their facility from 2008 to 2011 with ≥12 months of follow-up. A retrospective review of prospectively collected data was conducted. All returns (surgical readmission, office or emergency visit) for complications or recurrences were examined. The impact of demographics (age, gender, and body mass index [BMI]), risk factors (hernia grade, hernia size, concurrent and past bariatric surgery, concurrent and past organ transplantation, any concurrent surgery, and American Society of Anesthesiologists score), and prosthetic type (polypropylene, other synthetic, human acellular dermal matrix, non-cross-linked porcine-derived acellular dermal matrix, other biologic, or none) on the frequency of return was evaluated. A total of 564 patients had 12 months of follow-up, an...
The Egyptian Journal of Hospital Medicine, 2019
Background and aim: the ideal outcome of inguinal hernia surgery is to provide a repair that is free from recurrence, pain and infection with minimal scarring and with improvement in patient's quality of life. Aim of the work: this study aimed to compare light weight poliglecaprone (Ultrapropolypropylene/Monocryl), UltraPro™ mesh with the standard heavy weight polypropylene mesh in tension free Lichtenstein inguinal hernia repair. Patients and methods: the current study included 40 patients complained of uncomplicated inguinal hernia and they were randomized into two groups according to the type of mesh used in tension free Lichtenstein inguinal hernia repair. Group I, 20 patients received the standard polypropylene mesh. Group II, 20 patients received light weight UltraPro™ mesh, using sutures for their fixation. Results: the UltraPro™ (LWM) mesh proved to be as safe and effective as the standard (HWM) prolene mesh in repair of uncomplicated inguinal hernia. There was no difference between the two groups as regard to the technical difficulties, operative complications and surgeons were equally satisfied. There was more incidence of chronic pain with prolene mesh (25%) compared to (zero%) with UltraPro™ mesh. The mesh fixation time and the overall operative time were shorter with UltraPro™ mesh. Conclusion: the shorter operative time and the no-need to use analgesics could partially compensate the higher cost of UltraPro™ mesh in the absence of other economic factors such as the duration of patient improvement and return to work.