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

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

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.

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