Not fixating the mesh in open retromuscular ventral hernia repair (RVHR) was noninferior to fixation, a single-center clinical trial found.
Hernia recurrence rates at 1 year were similar between the transfascial suture fixation group versus the no fixation group (7.4% vs 9.2%, respectively, P=0.70), according to Ajita Prabhu, MD, of the Cleveland Clinic Center in Ohio, and co-authors.
The recurrence-adjusted risk difference was -0.02 (95% CI -0.07 to 0.04), with the upper CI bound of 0.043 landing below the predetermined margin of 0.10 needed for noninferiority, the researchers reported in JAMA Surgery.
Pain scores at 30 days and 1 year were similar between the two groups, as was opioid consumption. At 30 days, surgical site occurrences including serous drainage, superficial cellulitis, and seromas were 15.9% in the no fixation group versus 5.2% in the fixation group. There were no differences in reoperation or readmission rates at 30 days.
“Our findings challenge the notion that TF [transfascial] sutures are a requisite technical aspect of these operations, and we have abandoned them in our practice in patients meeting these criteria,” Prabhu and co-authors wrote.
“In surgery, we commonly say that the devil is in the details,” Prabhu said in an email to MedPage Today. “At the same time, it can be difficult to identify and suss out the individual contributions of each technical detail.”
Open RVHR with mesh was originally described with transfascial fixation sutures for mesh fixation, purportedly to keep mesh flat to allow ingrowth and take tension off of the midline fascial closure, the researchers noted.
“These theories led surgeons to believe mesh fixation may play a role in preventing hernia recurrence,” they wrote. But transfascial suture fixation also extends surgery times and could lead to more pain after surgery, the authors pointed out, with little evidence to support its utility in reducing midline tension or improving mesh ingrowth.
“Anecdotally, surgeons have noted during early reoperations that robust incorporation of permanent synthetic mesh in the retromuscular space occurs within a few days after placement, supporting the idea that long-term fixation may not be required,” wrote Benjamin Poulose, MD, MPH, and Courtney Collins, MD, MS, both of the Ohio State Wexner Medical Center in Columbus, in an accompanying editorial.
“Importantly, this study suggests that patients without fixation may be at higher risk of wound morbidity such as seromas,” the editorialists noted. “It is possible that transfascial fixation helps reduce the potential space that allows seromas to develop. Use of drains may help overcome this difference and should be considered in patients without transfascial fixation, whether undergoing open or minimally invasive repairs.”
“When forgoing transfascial fixation, surgeons should be even more judicious in the shape and size of the mesh to allow for optimal positioning, resulting in appropriate apposition of mesh to the abdominal wall,” Poulose and Collins wrote.
The randomized controlled trial ran at the Cleveland Clinic from 2019 to 2021, with patients completing 1-year follow-up by December of 2022. It included 325 patients with a ventral hernia defect width of 20 cm or less with fascial closure undergoing elective open RVHR.
Overall, 56.9% of patients were female and median age was 59, with 162 patients randomized to the mesh fixation group and 163 to the no mesh fixation group. Median BMI was 33. Follow-up was at 30 days and 1 year, and 82.8% had follow-up at 1 year.
The primary outcome was whether no transfascial suture fixation was noninferior to transfascial suture fixation with regard to recurrence at 1 year; a 10% noninferior margin was set. Secondary outcomes were postoperative pain and quality of life.
Pain scores were similar at any time point in the study. In-hospital intravenous and/or oral opioid consumption showed no differences with median morphine milliequivalents of 355 in the fixation group and 325 in the no fixation group (P=0.45), and a mean 5 mg oxycodone tablet use of 19.4 and 19.5, respectively, at 30 days.
Hernia-Related Quality-of-Life Survey scores were better in the no fixation group at 30 days (median score 53.3) versus the fixation group (median score 41.7, P=0.02). There were no reported differences in quality-of-life scores at 1 year.
Length of hospital stay was the same between the groups, and there were no significant differences in perceptions of feeling transfascial fixation sutures at 30 days and 1 year. Authors speculated that the no fixation group may have perceived sutures because of abdominal pain from retromuscular dissection.
Limitations included lack of a longer follow-up time and potential selection bias related to the size of mesh used, leading to varying ratios of mesh to hernia. In addition, the findings might not apply to the repair of other kinds of hernias.
“Transfascial sutures are not necessary in open abdominal wall reconstruction in hernias where the fascia can come back together and there is adequate mesh overlap,” Prabhu said. “But if the surgeon wants to place them due to concerns about recurrence, perhaps related to the location of the hernia, etc., they can do so with relative impunity.”
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Sophie Putka is an enterprise and investigative writer for MedPage Today. Her work has appeared in the Wall Street Journal, Discover, Business Insider, Inverse, Cannabis Wire, and more. She joined MedPage Today in August of 2021. Follow
Disclosures
Prabhu reported grant support from Intuitive Surgical, consulting for Verb Surgical and CMR Surgical, and serving on the advisory board of Surgimatix. Co-authors reported relationships with BD Biosciences, Surgimatix, Central Surgical Association, the Society of American Gastrointestinal and Endoscopic Surgeons, the American Hernia Society, Intuitive Surgical, the Abdominal Core Health Quality Collaborative, and Ariste Medical.
Poulose reported relationships with the Abdominal Core Health Quality Collaborative, BD Interventional, Advanced Medical Solutions, and EndoEvolve.
Primary Source
JAMA Surgery
Source Reference: Ellis RC, et al “Transfascial fixation vs no fixation for open retromuscular ventral hernia repairs” JAMA Surg 2023; DOI: 10.1001/jamasurg.2023.1786.
Secondary Source
JAMA Surgery
Source Reference: Collins CE, Poulose BK “Transfascial fixation vs no fixation for open retromuscular ventral hernia repairs — set it and forget it” JAMA Surg 2023; DOI: 10.1001/jamasurg.2023.1797.
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