NCT06066931

Reconstruction of the Pelvic Floor and Perineal Wound After Rectal ELAPE

Not yet recruiting NA Last updated 10 October 2023

What this trial tests

NA trial testing Plastic surgery of the pelvic floor and perineal wound with counter-displaced skin-subcutaneous fascial flaps after extralevatory abdominal-perineal extirpation of the rectum in Rectum Cancer in 150 participants. Not yet recruiting.

Timeline

1 October 2023

Primary endpoint
1 October 2025

1 October 2026

Quick facts

Lead sponsor	Kuban State Medical University
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	150
Start date	1 October 2023
Primary completion	1 October 2025
Estimated completion	1 October 2026

Drugs / interventions tested

• Plastic surgery of the pelvic floor and perineal wound with counter-displaced skin-subcutaneous fascial flaps after extralevatory abdominal-perineal extirpation of the rectum
• Plastic surgery of the pelvic floor and perineal wound with local tissues
• Plastic surgery of the pelvic floor and perineal wound with mesh endoprosthesis

Conditions studied

• Rectum Cancer — all drugs for Rectum Cancer →

Sponsor

Kuban State Medical University

Who can join

18 and older, any sex, with Rectum Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A multicenter, cohort, randomized, controlled study is being conducted since the 1of September, 2023 whereby the immediate and long-term results of pelvic floor and perineal wound plastic surgery after extralevatory abdominal-perineal extirpation of the rectum will be compared. The study is conducted on the basis of the Federal State Budgetary Educational Institution of the Ministry of Health Care of the Russian Federation, the Department of General Surgery at the clinical base of the State Budgetary Healthcare Institution " Krasnodar Regional Hospital No. 1 named after Professor S.V. Ochapovsky" of the Ministry of Health Care of the Krasnodar Territory, State Budgetary Healthcare Institution " Krasnodar Oncological Dispensary No. 1" of the Ministry of Health Care of the Krasnodar Territory The study included patients over 18 years old suffering from cancer of the lower ampullary rectum with T1-T4N0-2M0 (according to the classification of malignant tumors TNM in the 8th edition), who are scheduled for extralevatory abdominal-perineal extirpation of the rectum. Patients are randomized into 3 groups: the first group includes patients with plastic surgery in a simple way (Plastic surgery with local tissues), the second group includes patients with plastic surgery with a mesh endoprosthesis and the third one includes patients with plastic surgery in a new way.

The purpose of the study is to evaluate the effectiveness of the developed method of pelvic floor and perineal wound plastic surgery after extralevatory abdominal-perineal extirpation of the rectum. It is easily reproducible and provides high-quality closure of the deep and skin defect of the perineal wound. In addition, the new method will reduce the frequency of postoperative complications when compared with the use of conventional methods of closing the defect of the perineum, the method improves the quality of life and provides early rehabilitation of patients.

Study status- patients are being recruited. Number of patients selected is 150 patients. The primary endpoint of the study is the assessment of the early postoperative period and the frequency of postoperative complications (Flap necrosis; Suppuration; Hematoma; Bleeding; Seroma) within 30 days from the date of surgery. The study was approved by the Independent Ethics Committee Protocol No. 112 of 12th November, 2022.

It is planned to recruit patients within 2 years and monitor each of them for 30 days after surgery to assess the primary endpoint and to monitor patients within 1 year to assess the secondary endpoint. The secondary endpoint means an assessment of the frequency of late postoperative complications (perineal fistula, abscess, hernia) and an assessment of the quality of life within 1 year after surgery. It is planned to complete the study in 2025.

Eventually it is planned to publish the protocol of the study, the results obtained after the recruitment of the required number of patients as well as the results of evaluation of the primary endpoint.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.