NCT03445936

PRELOOP Trial: Synthetic Versus Biological Mesh for Prevention of Incisional Hernia After Loop-ileostomy Closure

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Oulu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study compares a synthetic mesh and biological implant in prevention of incisional hernia after loop-ileostomy closure.

Detailed description

Incisional hernia after loop-ileostomy closure may be an underestimated problem. Research on both biological and synthetic mesh in this context is scarce and no randomized controlled trials comparing meshes exist. The aim of this study is to compare Parietene Macro and Permacol in prevention of incisional site hernia after temporary loop-ileostomy reversal after anterior resection and TME for rectal cancer.

Conditions

• Rectum Cancer

Interventions

Type	Name	Description
DEVICE	Parietene Macro	Parietene Macro is placed and sutured on retro muscular space on closed posterior rectus sheath to prevent incisional hernia.
DEVICE	Permacol	Permacol biologic implant is placed and sutured on retro muscular space on closed posterior rectus sheath to prevent incisional hernia.

Timeline

• Start date: 2018-02-13
• Primary completion: 2022-10-30
• Completion: 2027-10-01
• First posted: 2018-02-26
• Last updated: 2024-02-01

Locations

4 sites across 1 country: Finland