Comparing Sugarbaker versus keyhole mesh technique for open retromuscular parastomal hernia repair: study protocol for a registry-based randomized controlled trial

• Published in: Current controlled trials in cardiovascular medicine Vol. 23; no. 1; p. 251
• Main Authors: Miller, Benjamin T, Thomas, Jonah D, Tu, Chao, Costanzo, Adele, Beffa, Lucas R A, Krpata, David M, Prabhu, Ajita S, Rosen, Michael J, Petro, Clayton C
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 04-04-2022; BioMed Central; BMC
• Subjects: Abdomen; Clinical trials; Consent; Hernia; Hernias; Herniorrhaphy - adverse effects; Herniorrhaphy - methods; Humans; Keyhole; Ostomy; Parastomal hernia; Prospective Studies; Quality of Life; Randomized controlled trial; Randomized Controlled Trials as Topic; Registries; Retromuscular; Study Protocol; Sugarbaker; Surgeons; Surgery; Surgical Mesh; Transversus abdominis release; United States; United States > US; Massachusetts; Ohio; Transversus abdominis release; Keyhole; Parastomal hernia; Sugarbaker; Randomized controlled trial; Retromuscular
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-022-06207-x

Parastomal hernia, common after stoma creation, negatively impacts patient quality of life. For patients with a permanent stoma, durable parastomal hernia repair remains a challenge, with few high-quality studies for guidance. An alternative to open retromuscular parastomal hernia repair with retromuscular "keyhole" mesh is the recent Sugarbaker modification. We aim to compare these two techniques in a head-to-head prospective study.
This is a registry-based randomized controlled trial designed to investigate whether the retromuscular Sugarbaker technique is superior to the retromuscular keyhole technique for parastomal hernia repair. The primary study endpoint is parastomal hernia recurrence at 2 years. Secondary endpoints include hospital length-of-stay, readmission, wound morbidity, mesh-related complications, re-operation, all 30-day morbidity, and patient-reported outcomes, including hernia-related quality of life, stoma-specific quality of life, pain, and decision regret.
Based on the post hoc analysis of a recent randomized controlled trial, we hypothesize that the retromuscular Sugarbaker technique will reduce parastomal hernia recurrence by 20% at 2 years compared to the retromuscular keyhole mesh technique. The results of this study may provide evidence-based guidance for surgeons repairing parastomal hernias.
ClinicalTrials.gov NCT03972553. Registered on 3 June 2019.