Gluteal turnover flap for closure of the perineal wound after abdominoperineal resection for rectal cancer, BIOPEX 2-study

Phase 3

Recruiting

Conditions: rectal cancer
Rectal malignancy
10002112
10040795

Registration Number: NL-OMON52518

Lead Sponsor: Amsterdam UMC, locatie AMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 160

Inclusion Criteria

(1) Resection of primary or recurrent rectal carcinoma by abdominoperineal
resection.
(2) Age of 18 years or older.
(3) Ability to return for all scheduled and required study visits.
(4) Written informed consent.

Exclusion Criteria

(1) The patient will undergo an intersphincteric abdminoperineal resection.
(2) Total pelvic exenteration or sacral resection above level S4/S5.
(3) Severe systemic diseases affecting wound healing except diabetes (i.e.
renal failure requiring dialysis, liver cirrhosis, and immune compromised
status like HIV).
(4) Collagen disorders (i.e. the syndrome of Marfan).
(5) Enrolment in trials with overlapping primary endpoint.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of the study is the percentage of uncomplicated perineal<br /><br>wound healing defined as a Southampton wound score of less than II at 30 days<br /><br>postoperatively.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1.) Surgery characteristics (duration of surgery, complications)<br /><br>2.) Effect of neoadjuvant treatment on PTP-flap healing<br /><br>3.) Perineal wound healing according to the Southampton wound grading at 14<br /><br>days, 3, 6 and 12 months postoperatively.<br /><br>4.) Cosmetic outcome and satisfaction with result .<br /><br>5.) Incidence of persistent perineal or presacral sinuses, both clinically and<br /><br>by imaging (routine follow-up CT).<br /><br>6.) Need for re-intervention or re-admission related to pre-sacral abscess or<br /><br>other perineal wound problems.<br /><br>7.) Length of hospital stay.<br /><br>8.) Incidence of symptomatic and asymptomatic perineal hernia during follow-up.<br /><br>9.) Quality of life and urogenital function (EQ 5D-5L, EORTC-QLQ-C30-QL2,<br /><br>EORTC-QLQ-CR29, SF36, UDI6, IIQ7, IIEF, FSDS-R, FSFI).<br /><br>10.) Postoperative pain score and duration.<br /><br>11.) Serious adverse events rate.</p><br>