Reconstruction of the Pelvic Floor and Perineal Wound After Rectal ELAPE

NCT06066931 | Not Yet Recruiting

• 1 other identifier: 28092023
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Rectum Cancer

Keywords

Cancer of the lower ampullary rectum; Extralevatory abdominal-perineal extirpation; Plastic surgery of the pelvic floor and perineal wound

Outcome Measures

Primary Outcomes (1)

• The assessment of the frequency of early postoperative complications

  Early postoperative complications to be assessed: flap necrosis; suppuration; hematoma; bleeding; seroma

  Within 30 days from the date of surgery

Secondary Outcomes (1)

• The assessment of the frequency of late postoperative complications and quality of life

  Within 1 year after surgery

Study Arms (3)

Group 1 of a simple method (Plastic surgery with local tissues) n=50

OTHER

In group 1 patients (plastic surgery with local tissues), a simple layer-by-layer suturing of the sciatic-anal and subcutaneous adipose tissue is performed using nodular sutures. The skin was sewn up with nodular sutures at the discretion of surgeons. The installation of abdominal drainage and/or perineal drainage was left to the discretion of the surgeon.

Procedure: Plastic surgery of the pelvic floor and perineal wound with local tissues

Group 2 is plastic surgery with a mesh endoprosthesis n=50

OTHER

In group 2 patients, a mesh allograft with an adhesive coating is inserted into the bottom of the wound, positioned horizontally between the inner surfaces of the ischial bones and vertically between the sacrum and the vagina in women or between the sacrum and the prostate gland in men. The mesh was sewn from behind on both sides of the coccyx or sacrum. From the side, the mesh was attached to the remainder of the levator muscle and from the front to the transverse muscles of the perineum. The installation of abdominal drainage and/or perineal drainage was left to the discretion of the surgeon. The sciatic-anal and subcutaneous fat are sutured using nodular sutures.

Procedure: Plastic surgery of the pelvic floor and perineal wound with mesh endoprosthesis

Group 3 is a new method of plastic surgery n=50

EXPERIMENTAL

In group 3 the plastic stage is performed: on one side of the perineal wound, a cutaneous-subcutaneous-fascial flap on the leg is cut out and deepithelized, along the entire length of the wound, thereby forming a diamond-shaped perineal wound, plunging it into the pelvic aperture, fixing it with single sutures to the remnants of the muscle lifting the anus of the opposite side, and the flap width is 3-4 cm to fill the pelvic aperture. On the opposite side of the wound, a triangular skin-subcutaneous fascial flap is cut out on a leg equal to the width of the previously formed diamond-shaped wound at an angle of 60-80 degrees from the middle of the wound edge, and the sides of the triangular flap should be equal to half the length of the edge of the diamond-shaped wound, then it is moved and additionally fill the wound cavity with it, in condition of displacement of the apex of the triangle flap with the top of the rhombus-wounds. The flap is fixed with separate skin nodular sutures.

Procedure: Plastic surgery of the pelvic floor and perineal wound with counter-displaced skin-subcutaneous fascial flaps after extralevatory abdominal-perineal extirpation of the rectum

Interventions

Plastic surgery of the pelvic floor and perineal wound with counter-displaced skin-subcutaneous fascial flaps after extralevatory abdominal-perineal extirpation of the rectum PROCEDURE

Skin-subcutaneous fascial flap on the leg is cut out from one side of the perineal wound, and deepithelized, forming a diamond-shaped perineal wound. The cut flap is immersed in the aperture of the pelvis and fixed with single sutures to the remains of levators of the opposite side. The flap width should be 3-4 cm, sufficient to fill the pelvic aperture. On the opposite side of the wound, a skin-subcutaneous fascial flap is cut out on a triangular leg equal to the width of the previously formed diamond-shaped wound. The flap is moved to the center of the wound, additionally filling wound cavity with it, combining the vertex of the triangle with the vertex of the rhombus. The perineal wound is drained through the contraperture. The flap is fixed with separate nodal seams.

Group 3 is a new method of plastic surgery n=50

Plastic surgery of the pelvic floor and perineal wound with local tissues PROCEDURE

Simple layer-by-layer suturing of the sciatic-anal and subcutaneous adipose tissue is performed using nodular sutures. The skin was sewn up with nodular sutures at the discretion of surgeons. The installation of abdominal drainage and/or perineal drainage was left to the discretion of the surgeon.

Group 1 of a simple method (Plastic surgery with local tissues) n=50

Plastic surgery of the pelvic floor and perineal wound with mesh endoprosthesis PROCEDURE

A mesh allograft with an adhesive coating is inserted into the bottom of the wound, positioned horizontally between the inner surfaces of the ischial bones and vertically between the sacrum and the vagina in women or between the sacrum and the prostate gland in men. The mesh was sewn from behind on both sides of the coccyx or sacrum. From the side, the mesh was attached to the remainder of the levator muscle and from the front to the transverse muscles of the perineum. The installation of abdominal drainage and/or perineal drainage was left to the discretion of the surgeon. The sciatic-anal and subcutaneous fat are sutured using nodular sutures.

Group 2 is plastic surgery with a mesh endoprosthesis n=50

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years old suffering from cancer of the lower ampullary rectum cT1-T4N0-2M0 (according to the classification of malignant tumors TNM in the 8th edition).
• Patients with planned extralevatory abdominal-perineal extirpation of the rectum.
• Physical status of patients according to ASA classification I-II.
• Signed informed consent to participate in the study.
• Verification of the squamous cell carcinoma diagnosis.
• The presence of acute purulent processes in the area of surgical intervention.

You may not qualify if:

• Refusal to participate at any stage of the study.
• Death in the early postoperative period (up to 30 days after surgery) caused by somatic complications not associated with surgery (PATE, myocardial infarction, stroke).

Sponsors & Collaborators

• Kuban State Medical University: lead
• State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital: collaborator
• City Clinical Oncology Hospital No 1: collaborator

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Vadim V Polovinkin, MD

  Kuban State Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vadim V Polovinkin, MD

CONTACT

+79186566727; vvpolovinkin@gmail.com

Nikolay V Doronin

CONTACT

+79186265513; nikolajdoronin23@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Medical Sciences, Head of the Department of General Surgery of Kuban State Medical University

Model Details: It is planned to recruit patients over the age of 18, 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 meet the inclusion criteria taking into account the exclusion criteria in the number of 150 people. Group 1 is a simple method (Plastic surgery with local tissues) n=50; Group 2 is plastic surgery with a mesh endoprosthesis n=50; group 3 is a new method of plastic surgery n=50.

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 4, 2023
• Study Start: October 1, 2023
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share