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Randomized Controlled Trial
. 2024 Sep 1;159(9):982-989.
doi: 10.1001/jamasurg.2024.1686.

Open Retromuscular Sugarbaker vs Keyhole Mesh Placement for Parastomal Hernia Repair: A Randomized Clinical Trial

Sara M Maskal  1 , Ryan C Ellis  1 , Aldo Fafaj  1 , Adele Costanzo  1 , Jonah D Thomas  2 , Ajita S Prabhu  1 , David M Krpata  1 , Lucas R A Beffa  1 , Chao Tu  1 , Xinyan Zheng  3 , Benjamin T Miller  1 , Michael J Rosen  1 , Clayton C Petro  1
Affiliations
Randomized Controlled Trial

Open Retromuscular Sugarbaker vs Keyhole Mesh Placement for Parastomal Hernia Repair: A Randomized Clinical Trial

Sara M Maskal et al. JAMA Surg. .

Abstract

Importance: Durable parastomal hernia repair remains elusive. There is limited evidence comparing the durability of the open retromuscular Sugarbaker and keyhole mesh configurations.

Objective: To determine if the open retromuscular Sugarbaker mesh placement technique would lower parastomal hernia recurrence rates.

Design, setting, and participants: In this single-center, randomized clinical trial, 150 patients with a permanent stoma and associated parastomal hernia who were candidates for open retromuscular parastomal hernia repair were enrolled and randomized from April 2019 to April 2022 and followed up for 2 years.

Interventions: Following intraoperative assessment to determine the feasibility of either technique, enrolled patients were randomized to receive either retromuscular Sugarbaker or keyhole synthetic mesh placement.

Main outcomes and measures: The primary outcome was parastomal hernia recurrence at 2 years. Secondary outcomes included mesh-related complications, wound complications, reoperations, as well as patient-reported pain, abdominal wall-specific quality of life, stoma-specific quality of life, and decision regret at 1 year and 2 years.

Results: A total of 150 patients were randomized, and with 91% follow-up at 2 years, there were 13 (17%) parastomal hernia recurrences in the retromuscular Sugarbaker arm and 18 (24%) in the keyhole arm (adjusted risk difference, -0.029; 95% CI, -0.17 to 0.153, and adjusted risk ratio, 0.87; 95% CI, 0.42 to 1.69). There were no statistically significant differences between the Sugarbaker and keyhole groups regarding reoperations for recurrence (2 vs 7, respectively), nonhernia intra-abdominal pathology (4 vs 10, respectively), stoma necrosis (1 vs 0, respectively), mesh-related complications (4 vs 1, respectively), patient-reported pain, abdominal wall-specific quality of life, stoma-specific quality of life, and decision regret at any time point.

Conclusions and relevance: In the setting of open parastomal hernia repair, a retromuscular Sugarbaker mesh placement technique was not superior to a keyhole configuration 2 years after repair. Further innovation is necessary to improve parastomal hernia repair outcomes.

Trial registration: ClinicalTrials.gov Identifier: NCT03972553.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Maskal reported a resident research grant from the Abdominal Core Health Quality Collaborative (ACHQC) outside the submitted work. Dr Prabhu reported speaking fees and research support paid to their institution from Intuitive Surgical and consulting and/or advisory board fees from CMR Surgical and Surgimatix during the conduct of the study. Dr Beffa reported honoraria from Intuitive Surgical. Dr Miller reported a research grant from the American Hernia Society and Integra. Dr Rosen reported salary support as the medical director of the ACHQC, grants to their institution from Tela Bio, and stock options with Ariste outside the submitted work. Dr Petro reported research grants from the Central Surgical Association, American Hernia Society, and SAGES and consultant fees from Advanced Medical Solutions, BD, and Surgimatix outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. CONSORT Diagram
MIS indicates minimally invasive surgery; PRO, patient-reported outcomes.
Figure 2.
Figure 2.. Kaplan-Meier Plot for Parastomal Hernia Recurrence
See this image and copyright information in PMC

Comment on

References

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