APEMESH- Preventing Perineal Complications After Abdominoperineal Resection

Completed

• Conditions: Wound Heal; Abdominoperineal Resection; Rectal Cancer
• Interventions: Device: Composite mesh

• Registration Number: NCT04334421
• Lead Sponsor: Elisa Mäkäräinen

Brief 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.

Study Timeline

• Study First Submitted: 2020-04-01
• Study First Submitted QC: 2020-04-01
• Study Start: 2020-04-03
• Study First Posted: 2020-04-06
• Primary Completion: 2021-02-28
• Study Completion: 2022-02-28
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mesh group	Composite mesh	After resection, pelvic floor is reconstructed by synthetic composite mesh (Symbotex, Medtronic) and covered with subcutaneous flap.

Primary Outcome Measures

Name	Time	Method
Comprehensive Complication index	30 days	Comprehensive Complication index is used to evaluate outcome

Secondary Outcome Measures

Name	Time	Method
Length of stay	30 days	Length of stay at the hospital during primary operation and recovery
Costs	30 days	Costs by materials used
Perineal sinus	30 days	Presence of perineal sinus at 30 days follow-up
Perineal hernia	12 months	Perineal hernia by CT scan at 12 months follow-up
Operative time	30 days	Operative time
Surgical site infection	30 days	Surgical site infection classified by Clavien-Dindo score
Reoperation rate	30 days	Reoperations during primary stay at the hospital
Total perineal healing time	30 days	Time to point when perineum is closed and healed

Trial Locations

Locations (1)

Oulu University Hospital; 🇫🇮 Oulu, Finland