Central Surgical AssociationA prospective, randomized, multicenter trial of Surgisis Gold, a biologic prosthetic, as a sublay reinforcement of the fascial closure after open bariatric surgery
Section snippets
Methods
This industry-funded study (Cook Biotech, Inc) was designed as a multicenter, prospective, randomized trial in patients undergoing open Roux-en-Y gastric bypass (RYGB) at two medical centers: Virginia Commonwealth Surgeons, Richmond, Virginia, and Mayo Clinic, Rochester, Minnesota. This study was approved by the Institutional Review Boards of the two participating medical centers and registered at www.ClinicalTrials.gov as NCT00274625. Informed consent to participate was obtained from all
Results
A total of 402 patients were enrolled in this study and comprised the intention-to-treat population across the two participating sites (Fig 2). Of these 402 patients, 199 were randomized to the Surgisis Gold arm, 14 of whom were eventually excluded; 203 were randomized to the suture arm, 8 of whom were excluded. Patients were excluded either intraoperatively at the time of skin incision and exposure of the fascia because they did not meet the inclusion criteria of the study despite being
Discussion
This prospective, randomized trial was designed to determine whether an intraperitoneal, bioprosthetic sublay using Surgisis Gold to reinforce a primary fascial closure would decrease the incidence of incisional hernia formation at 2 years postoperatively in patients undergoing elective open RYGB. Unfortunately, the study showed that there was no benefit of the use of this bioprosthesis within the confines of this study; the rate of incisional hernia formation with and without the bioprosthesis
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Hernia Prevention: The Role of Technique and Prophylactic Mesh to Prevent Incisional Hernias
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2021, Journal of Surgical ResearchMesh position for hernia prophylaxis after midline laparotomy: A systematic review and network meta-analysis of randomized clinical trials
2020, International Journal of SurgeryCitation Excerpt :OM was a little better than RM in IH prophylaxis, with lower risk of hematoma and dehiscence but slightly higher risk of infection and seroma. Sensitivity analyses were performed by excluding absorbable/biologic mesh [15,21,22,27]. The effects of OM, RM, and IM were relatively unchanged, whereas the treatment effect of PM became marginally significant when compared with PSC.
Prevention of Fascial Dehiscence with Onlay Prophylactic Mesh in Emergency Laparotomy: A Randomized Clinical Trial
2020, Journal of the American College of SurgeonsCitation Excerpt :During fascial suturing, the SL/WL ratio of ≥4.0 was achieved in fewer than half of the cases in the SG. Some studies of prophylactic mesh have performed fascial suturing without concern for the SL/WL ratio,24,26,33 and others have indicated that the target should be an SL/WL ratio ≥4.0, but did not measure the actual value achieved.17,20,23,25,54,55 In practice, achieving this goal is not a simple task.