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. 2023 Aug 1;158(8):789-795.
doi: 10.1001/jamasurg.2023.1786.

Transfascial Fixation vs No Fixation for Open Retromuscular Ventral Hernia Repairs: A Randomized Clinical Trial

Ryan C Ellis  1 , Clayton C Petro  1 , David M Krpata  1 , Lucas R A Beffa  1 , Benjamin T Miller  1 , Katie C Montelione  1 , Sara M Maskal  1 , Chao Tu  2 , Li-Ching Huang  3 , Braden Lau  1 , Aldo Fafaj  1 , Steven Rosenblatt  1 , Michael J Rosen  1 , Ajita S Prabhu  1
Affiliations

Transfascial Fixation vs No Fixation for Open Retromuscular Ventral Hernia Repairs: A Randomized Clinical Trial

Ryan C Ellis et al. JAMA Surg. .

Erratum in

  • Error in Abstract and Results.
    [No authors listed] [No authors listed] JAMA Surg. 2023 Aug 1;158(8):892. doi: 10.1001/jamasurg.2023.3576. JAMA Surg. 2023. PMID: 37555858 Free PMC article. No abstract available.

Abstract

Importance: Transfascial (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.

Objective: To 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 participants: In 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.

Interventions: Eligible patients were randomized to mesh fixation with percutaneous TF sutures or no mesh fixation with sham incisions.

Main outcome and measures: The 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.

Results: A total of 325 adults (185 women [56.9%]; median age, 59 [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 relevance: The 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 registration: ClinicalTrials.gov Identifier: NCT03938688.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Petro reported consulting for BD Biosciences and Surgimatix, Inc, outside the submitted work and receiving grant support from the Central Surgical Association, the Society of American Gastrointestinal and Endoscopic Surgeons, and the American Hernia Society. Dr Beffa reported receiving personal fees from Intuitive Surgical, Inc, during the conduct of the study. Dr Rosen reported serving as medical director of Abdominal Core Health Quality Collaborative and receiving stock options from Ariste Medical, LLC, outside the submitted work. Dr Prabhu reported receiving grant support from Intuitive Surgical, Inc, consulting for Verb Surgical and CMR Surgical, and serving on the advisory board of Surgimatix, Inc. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. CONSORT Diagram
HRI indicates Hernia Recurrence Inventory; MIS, minimally invasive surgery.
Figure 2.
Figure 2.. Pain Scores
A, Pain as measured by Patient Reported Outcome Measurement Information System (PROMIS) Pain Intensity short form scores at baseline and postoperatively at 30 days and 1 year. Three questions are answered on a scale of 1 to 5, where 1 indicates no pain; raw scores are converted to T-scores, with higher values meaning more pain. B, Pain as measured by Numeric Pain Rating Scale (NRS-11) scores at baseline and postoperative days (POD) 1 to 7 and 30 and 1 year. Scores range from 0 to 10, where 10 is the worst pain imaginable. Scores were significantly different on POD 1 and 6. Error bars represent 95% CIs. The number of patients represents how many individuals provided scores at each time point.
Figure 3.
Figure 3.. Quality of Life Measured by HerQLes Scores
Scores range from 0 to 100, with higher scores representing improved quality of life and abdominal wall function. Error bars represent 95% CIs. The number of patients represents how many individuals provided scores at each time point.
See this image and copyright information in PMC

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  • Error in Abstract and Results.
    [No authors listed] [No authors listed] JAMA Surg. 2023 Aug 1;158(8):892. doi: 10.1001/jamasurg.2023.3576. JAMA Surg. 2023. PMID: 37555858 Free PMC article. No abstract available.

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