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

University of Oulu

Status

Active, not recruiting

Conditions

Rectum Cancer

Treatments

Device: Permacol

Device: Parietene Macro

Study type

Interventional

Funder types

Other

Identifiers

NCT03445936

317/2017

Details and patient eligibility

About

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

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Anterior resection and TME with temporary loop-ileostomy for rectal carcinoma
18 years or older
Patient has a life expectancy of at least 12 months.
Patient signs the Informed consent and agrees to attend all study visits

Exclusion criteria

Patient with a comorbid illness or condition that would precluded the use of surgery (ASA 4-5).
Patients with concurrent or previous malignant tumors within 5 years before study enrollment
Patients with T4b tumors which imposed a multi-organ resection
Patient undergone emergency procedures
Primary rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections).
Metastatic disease with life expectancy of less than 12 months
Pregnancy or suspected pregnancy