Transfascial Fixation vs No Fixation for Open Retromuscular Ventral Hernia Repairs

Abstract

ImportanceTransfascial (TF) mesh fixation in open retromuscular ventral hernia repair (RVHR) has been advocated to reduce hernia recurrence. However, TF sutures may cause increased pain, and, to date, the purported advantages have never been objectively measured.ObjectiveTo determine whether abandonment of TF mesh fixation would result in a noninferior hernia recurrence rate at 1 year compared with TF mesh fixation in open RVHR.Design, Setting, and ParticipantsIn this prospective, registry-based, double-blinded, noninferiority, parallel-group, randomized clinical trial, a total of 325 patients with a ventral hernia defect width of 20 cm or less with fascial closure were enrolled at a single center from November 29, 2019, to September 24, 2021. Follow-up was completed December 18, 2022.InterventionsEligible patients were randomized to mesh fixation with percutaneous TF sutures or no mesh fixation with sham incisions.Main Outcome and MeasuresThe primary outcome was to determine whether no TF suture fixation was noninferior to TF suture fixation for open RVHR with regard to recurrence at 1 year. A 10% noninferior margin was set. The secondary outcomes were postoperative pain and quality of life.ResultsA total of 325 adults (185 women [56.9%]; median age, 33 [IQR, 50-67] years) with similar baseline characteristics were randomized; 269 patients (82.8%) were followed up at 1 year. Median hernia width was similar in the TF fixation and no fixation groups (15.0 [IQR, 12.0-17.0] cm for both). Hernia recurrence rates at 1 year were similar between the groups (TF fixation, 12 of 162 [7.4%]; no fixation, 15 of 163 [9.2%]; P = .70). Recurrence-adjusted risk difference was found to be −0.02 (95% CI, −0.07 to 0.04). There were no differences in immediate postoperative pain or quality of life.Conclusions and RelevanceThe absence of TF suture fixation was noninferior to TF suture fixation for open RVHR with synthetic mesh. Transfascial fixation for open RVRH can be safely abandoned in this population.Trial RegistrationClinicalTrials.gov Identifier: NCT03938688

End Points and Statistical Analyses in a Trial of Transfascial Fixation for Open Retromuscular Ventral Hernia Repairs—Reply

“…In Reply We thank the authors for their insightful comments on our trial . The correct reference for our decision to use the pragmatic hernia recurrence definition is reference 13 in our article .…”

End Points and Statistical Analyses in a Trial of Transfascial Fixation for Open Retromuscular Ventral Hernia Repairs

“…To the Editor Clear and unequivocal definition of the primary end point is a pillar of success of a noninferiority clinical trial. Ellis et al defined their primary outcome as “the rate of pragmatic hernia recurrence at 1 year, determined by a weighted formula consisting of physical examination, computed tomographic scan, and the Hernia Recurrence Inventory questionnaire as previously described by Krpata et al” However, the reference in question does not describe the Hernia Recurrence Inventory or address the weighting formula. Furthermore, per eTable 1, the authors did not apply statistical weighting adjustments, but rather deferred to clinical and radiographic evaluation in cases of discrepancies with patient responses.…”