NCT04334421

APEMESH- Preventing Perineal Complications After Abdominoperineal Resection

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Elisa Mäkäräinen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Rectal Cancer
• Abdominoperineal Resection
• Wound Heal

Interventions

Type	Name	Description
DEVICE	Composite mesh	Pelvic floor is reconstructed by synthetic composite mesh (Symbotex, Medtronic) to improve healing and prevent perineal herniation.

Timeline

• Start date: 2020-04-03
• Primary completion: 2021-02-28
• Completion: 2022-02-28
• First posted: 2020-04-06
• Last updated: 2024-02-01

Locations

1 site across 1 country: Finland