Clinical Research Directory

SUTURE TYPE AND RECURRENCE RISK AFTER INCISIONAL HERNIA REPAIR

Sponsor: Ersta Diakoni

Summary

Incisional hernia is a common condition after abdominal surgery and is often associated with pain, impaired physical function, and reduced quality of life. It may also be complicated by incarceration and strangulation, with the potential for acute and life-threatening events. Surgical repair is the only curative treatment, and in many cases requires complex abdominal wall reconstruction, with substantial morbidity and a risk of recurrence. In recent years, minimally invasive laparoscopic and robot-assisted surgery has gained an increasingly important role in the treatment of ventral hernias. Retromuscular mesh placement combined with closure of the fascial defect has been developed to combine biomechanical principles from open Rives-Stoppa reconstruction with the potential benefits of minimally invasive techniques. A key knowledge gap is which suture material should be used for defect closure: non-absorbable sutures, which provide permanent mechanical stability but leave permanent foreign material, or slowly absorbable sutures, which degrade over time and may reduce suture-related complications. In clinical practice, the choice is often driven by local tradition and surgeon preference rather than robust evidence. Evidence from abdominal wall closure after elective laparotomy supports the use of slowly absorbable suture material; however, those results cannot be directly transferred to minimally invasive ventral hernia surgery where mesh reinforcement, biomechanics, and healing processes differ. Randomized multicenter trials specifically evaluating the impact of suture material in laparoscopic or robot-assisted retromuscular ventral/incisional hernia repair are lacking. Against this background, the present trial compares slowly absorbable versus non-absorbable sutures in minimally invasive retromuscular incisional hernia repair, focusing on an objective long-term endpoint. CT-verified recurrence at 2 years was chosen as the primary endpoint to provide a robust and clinically meaningful measure of treatment effect. The hierarchical hypothesis framework (primary test of superiority and secondary test of non-inferiority) allows a clinically useful interpretation even if no statistically significant advantage is demonstrated. Although incisional hernia is a subset of ventral hernias and shares pathophysiological and surgical principles with other ventral hernias, this trial is restricted to incisional hernia, where recurrence is more common and suture choice is expected to be more decisive. This restriction aims to achieve a more homogeneous study population and improve internal validity

Official title: Non-absorbable Versus Slowly Absorbable Sutures in Minimally Invasive Retromuscular Incisional Hernia Repair: a Randomized Multicenter Trial of CT-verified Recurrence at 2 Years

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