A clinical trial conducted at the Cleveland Clinic Center in Ohio has shown that not fixating the mesh in open retromuscular ventral hernia repair (RVHR) is noninferior to fixation. The study, which was conducted on 325 patients, found that hernia recurrence rates at 1 year were similar between the transfascial suture fixation group and the no fixation group.
Study Findings
According to the study’s co-authors, pain scores at 30 days and 1 year were similar between the two groups, as was opioid consumption. The 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 at 30 days. There were no differences in reoperation or readmission rates at 30 days.
The recurrence-adjusted risk difference was -0.02, with the upper CI bound of 0.043 landing below the predetermined margin of 0.10 needed for noninferiority. This suggests that no mesh fixation is noninferior to mesh fixation in preventing hernia recurrence.
Mesh Fixation
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.
However, 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.
Editorialists’ Comments
In an accompanying editorial, Benjamin Poulose, MD, MPH, and Courtney Collins, MD, MS, both of the Ohio State Wexner Medical Center in Columbus, noted that “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.”
The study’s authors concluded that “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.” The randomized controlled trial ran from 2019 to 2021, with patients completing 1-year follow-up by December of 2022.
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.
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