NCT01965249

Effect of Stitch Technique on the Occurrence of Incisional Hernia After Abdominal Wall Closure

Short Stitch Versus Long Stitch Suture Technique Using Monomax® for Abdominal Wall Closure After Primary Median Laparotomy. A Randomized, Controlled, Double-blinded, Multicenter, International Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 425 (actual)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The major long term complication of abdominal wall closure after a median laparotomy is the development of an incisional hernia. Several suture technique and suture material have been used but the incidence of this complication still lies between 9 -20%. Synthetic suture material which have become available over the last decades have the advantage that they are degraded by the body system and fully absorbed within 70-180 days; however they loss 50% of their initial strength already after 14-30 days and may not be the optimal suture material for abdominal wall closure. A new suture material (Monomax®) was developed with an extra-long absorption profile, high elasticity and with a superior initial strength. Therefore, the ESTOIH-Study was designed to investigate the influence of the stitch length on the occurrence of incisional hernia using the extra-long term absorbable, elastic, monofilament suture (Monomax®).

Conditions

• Injury of Abdominal Wall

Interventions

Type	Name	Description
DEVICE	Long stitch	AWC with the long stitch technique using MonoMax USP 1, 150 cm loop, HR48 mm
DEVICE	Short Stitch	Short stitch suture technique using MonoMax USP 2/0, 150 cm, HR26 mm

Timeline

• Start date: 2014-02-01
• Primary completion: 2019-12-15
• Completion: 2024-12-12
• First posted: 2013-10-18
• Last updated: 2025-09-08

Locations

9 sites across 2 countries: Austria, Germany