APEMESH II - Perineal Reconstruction

Not Applicable

Completed

• Conditions: Rectal Cancer

• Registration Number: NCT04779125
• Lead Sponsor: University of Oulu

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-02-22
• Study First Submitted QC: 2021-03-02
• Study First Posted: 2021-03-03
• Study Start: 2021-03-19
• Primary Completion: 2022-03-01
• Study Completion: 2022-03-01
• 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

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Complications	30 days	Comprehensive complication index

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	30 days	Primary length of stay at the hospital
Costs of treatment materials	30 days	Costs of treatment materials
Total perineal healing time	1 year	Time from operation to complete perineal healing
Perineal fistula	30 days	Perineal sinus or fistula
Perineal hernia	12 months	Perineal hernia incidence
Gluteus muscle function measured by time stands test	12 months	Gluteus muscle function measured by time stands test
Reoperation rate	30 days	Reoperation rate
Surgical site infections	30 days	Surgical site infections
Operative time	30 days	Operative time to reconstruct perineum

Trial Locations

Locations (1)

Oulu University Hospital; 🇫🇮 Oulu, Finland