APEMESH- Preventing Perineal Complications After Abdominoperineal Resection

Elisa Mäkäräinen

Status: Completed

Conditions: Wound Heal; Abdominoperineal Resection; Rectal Cancer

Treatments: Device: Composite mesh

Study type: Observational

Funder types: Other

Identifiers

NCT04334421

57/2020

Details and patient eligibility

About

Abdominoperineal resection leaves an empty space to be filled by mesh or musculocutaneus flap. Several studies have reported over 30% morbidity with perineal wound healing after abdominoperineal resection. Preoperative radiotherapy is a strong predictor for perineal complications. Musculocutaneus flaps and use of biological mesh seem to minimize perineal morbidity. The role of omentoplasty at APR is controversial.

Previous studies on synthetic mesh repair on perineum are almost lacking.

Full description

The objective of this pilot study is to assess the feasibility and the potential benefits of synthetic mesh reconstruction in perineum in case-control setting.

30 subjects will be prospectively enrolled to this study as intervention group. Controls matched with age, gender and preoperative radiotherapy are selected from retrospective data collected from Oulu University database and operated for rectal adenocarcinoma 2009-2017 with otherwise identical methods.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Abdominoperineal resection and permanent colostoma

Exclusion criteria

• Patient with a comorbid illness of condition that would preclude the use of surgery (ASA5)
• Potentially curable resection not possible
• Patient undergoing emergency procedure
• Metastatic disease
• Pregnant or suspected pregnancy

Trial design

30 participants in 1 patient group

Mesh group

Description:

After resection, pelvic floor is reconstructed by synthetic composite mesh (Symbotex, Medtronic) and covered with subcutaneous flap.

Treatment:

Device: Composite mesh