Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Hernia

Incisional Hernia

Rectal Neoplasms

Pathological Conditions, Anatomical

Postoperative Complications

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Parietene Macro is a macroporous synthetic mesh used in retro muscular sublay position to prevent incisional hernia after loop-ileostomy closure.

Permacol is a acellular porcine dermal implant used in retro muscular sublay position to prevent incisional hernia after loop-ileostomy closure.

Parietene Macro is placed and sutured on retro muscular space on closed posterior rectus sheath to prevent incisional hernia.

Parietene Macro

Permacol biologic implant is placed and sutured on retro muscular space on closed posterior rectus sheath to prevent incisional hernia.

Permacol

Elisa Mäkäräinen-Uhlbäck

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

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.

This is a prospective randomized controlled multicenter trial

Subject is blinded of the mesh used. Outcome at 10 month follow-up is assessed by surgeon who was not involved in the operation.

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

The incidence of surgical site infections at 30 days follow up

Clavien-Dindo I-V complications at 30 days follow-up

Demand for re-operations related to mesh or complications

Time (min) needed for operation and application of mesh/implant

Length of stay at the hospital after the operation

Quality of life after the operation measured by RAND 36

Analysis of costs to both individual and community

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
PRELOOP Trial: Synthetic Versus Biological Mesh for Prevention of Incisional Hernia After Loop-ileostomy Closure	NCT03445936	Rectum Cancer	Parietene Macro Permacol	18 Years -	University of Oulu
PRELOOP Trial: Synthetic Versus Biological Mesh for Prevention of Incisional Hernia After Loop-ileostomy Closure	NCT03445936	Rectum Cancer	Parietene Macro Permacol	18 Years -	University of Oulu

Spots Global Cancer Trial Database for parietene macro