ongterm outcome of biological mesh closure of the pelvic floor after extralevator abdominoperineal resection for rectal cancer.

Phase 3

Completed

• Conditions: rectal cancer; Rectal malignancy; 10002112; 10017998

• Registration Number: NL-OMON45096
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 104

Inclusion Criteria

(1) Primary rectal cancer
(2) Age of 18 years or higher
(3) Planned for extralevator abdominoperineal excision after neo-adjuvant (chemo)radiotherapy
(4) Life expectancy of more than 2 years
(5) Ability to return for all scheduled and required study visits
(6) Written informed consent for study participation

Exclusion Criteria

(1) Previous pelvic irradiation for other cancers (i.e. prostate cancer)
(2) Total exenteration or sacral resection above level S4/S5)
(3) Sensitivity to porcine derived products or polysorbate
(4) Severe systemic diseases affecting wound healing
(5) The patient has a collagen diseases
(6) Participation of the patient in other scientific research affecting wound healing
(7) Non-correctable coagulopathy (INR>2; or platelets <90E9 109/l) present
(8) ASA-classification * 4

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Percentage of uncomplicated perineal wound healing (Souphampton wound score<br /><br>less than II on<br /><br>day 30). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Hospital stay, incidence of perineal hernia, quality of life, and costs.</p><br>