Synthetic Versus Biological Mesh in Laparoscopic and Open Ventral Hernia Repair (LAPSIS)

Abstract

Objective: The aim of this study was to investigate the approach (open or laparoscopic) and mesh type (synthetic or biological) in ventral hernias in a clean setting. Summary of Background Data: The level of evidence on the optimal surgical approach and type of mesh in ventral hernia repair is still low. Methods: Patients with a ventral abdominal hernia (diameter 4–10 cm) were included in this double-blind randomized controlled trial across 17 hospitals in 10 European countries. According to a 2 × 2-factorial design, patients were allocated to 4 arms (open retromuscular or laparoscopic intraperitoneal, with synthetic or Surgisis Gold biological mesh). Patients and outcome assessors were blinded to mesh type used. Major postoperative complication rate (hernia recurrence, mesh infection, or reoperation) within 3 years after surgery, was the primary endpoint in the intention-to-treat population. Results: Between September 1st, 2005, and August 7th, 2009, 253 patients were randomized and 13 excluded. Six of 61 patients (9.8%) in the open synthetic mesh arm, 15 of 66 patients (22.7%) in the open biological mesh arm, 7 of 64 patients (10.9%) in the laparoscopic synthetic mesh arm and 17 of 62 patients (27.4%) in the laparoscopic biological mesh arm had a major complication. The use of biological mesh resulted in significantly more complications (P = 0.013), also after adjusting for hernia type, body mass index, and study site. The trial was prematurely stopped due to an unacceptable high recurrence rate in the biological mesh arms. Conclusions: The use of Surgisis Gold biological mesh is not recommended for noncomplex ventral hernia repair. Trial Registration: This trial was registered at controlled-trials.com (ISRCTN34532248).

Synthetic Versus Biological Mesh in Ventral Hernia Repair and Abdominal Wall Reconstruction: A Systematic Review and Recommendations from Evidence‐Based Medicine

“…The mean BMI of the included patients was relatively high, from 26.9 (standard deviation, SD:5.7) to 38.6 (SD:9.6). Four studies were randomized controlled trials [8][9][10]18] while the remaining six were retrospective [13][14][15][16][17]19]. Nine studies reported the wound class in detail, and 30.1% of the patients had clean wounds (n = 346).…”

“…Five studies reported the location of the mesh [13,14,[17][18][19], and the majority of the mesh position were retro muscular (n = 357, 70.6%), followed by preperitoneal (n = 106, 20.9%). The surgical approach was open in six studies [8,9,[16][17][18][19], one study used both open and laparoscopic surgical techniques [10], and three studies did not report this. Overall, there was considerable variation in fascial closure rates across studies, as well as in component separation rates.…”

Physiologic Cyclical Load on Inguinal Hernia Scaffold ProFlor Turns Biological Response into Tissue Regeneration

“…In these patients, biopsy samples were removed from the 3D scaffold for histological examination. The investigation utilized the same biopsy samples used for previous studies removed from 15 individuals between 2010–2015 [ 20 , 21 , 22 , 23 , 24 ]. The 3D scaffold ProFlor, produced by Insightra Medical Inc. Clarksville, TN—USA, is designed with a 3D core with a cylindrical multilamellar outline, with reinforced margins, and is manufactured with low weight with large porous polypropylene, and has a thickness of 0.15 mm.…”

“…Based on recent evidence on functional anatomy and pathogenesis, a new concept of cure has been developed to manage inguinal protrusions. It concerns a newly designed 3D device, a scaffold named ProFlor, whose dynamic and regenerative features seem to resolve all specific issues deriving from the use of flat meshes in inguinal hernia repair [ 19 , 20 , 21 ]. The proprietary centrifugal expansion of ProFlor allows for a permanent obliteration of the hernia defect without need for fixation.…”

Current Insights: The Impact of Gut Microbiota on Postoperative Complications in Visceral Surgery—A Narrative Review

“…The occurrence of postoperative complications is in addition a significant economic burden for healthcare systems [2,5,6]. Major complications are rare in case of minor surgery in healthy patients, but occur in up to 50% of patients undergoing complex visceral surgery such as pancreas, liver or esophagus surgery [7][8][9].…”