APEMESH II - Perineal Reconstruction

University of Oulu

Status: Completed

Conditions: Rectal Cancer

Treatments: Procedure: Gluteus plasty enhanced with Progrip self gripping mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT04779125

115/2020

Details and patient eligibility

About

The objective of this pilot study is to assess the safety, functional outcome, feasibility and the potential benefits of synthetic mesh strip and gluteus flap reconstruction in perineum in case-control setting.

Full description

Several studies have reported over 30% morbidity with perineal wound healing after abdominoperineal resection. Preoperative radiotherapy seems to be a strong predictor for perineal complications. Musculocutaneus flaps and use of biological mesh seem to minimize perineal morbidity.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Curative intent abdominoperineal resection and permanent colostomy

Exclusion criteria

• Patient with a comorbid illness or condition that would preclude the use of surgery (ASA 4- 5)
• Immunosupression (cortisone >10mg/day) or severe malnutrition (BMI <20)
• Diabetes with 1 or more organ damage
• Dialysis treatment
• Hepatic cirrhosis Child-Bugh B-C
• Potentially curable resection not possible
• Patient undergoing emergency procedures
• Metastatic disease
• Vaginal resection, pelvic exenteration and sacrum resection
• Vaginal perforation
• Pelvic abscess or perforated tumor
• Pregnant or suspected pregnancy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Gluteus plasty enhanced with Progrip self gripping mesh

Experimental group

Description:

All study patietns will have a gluteus enhanced plasty after abdominoperineal reconstruction.

Treatment:

Procedure: Gluteus plasty enhanced with Progrip self gripping mesh