Reconstruction of the Pelvic Floor and Perineal Wound After Rectal ELAPE

NANot yet recruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

October 1, 2023

Primary Completion Date

October 1, 2025

Study Completion Date

October 1, 2026

Conditions
Rectum Cancer
Interventions
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

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.

PROCEDURE

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

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 mesh endoprosthesis

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.

All Listed Sponsors
collaborator

State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital

OTHER_GOV

collaborator

City Clinical Oncology Hospital No 1

OTHER_GOV

lead

Kuban State Medical University

OTHER

NCT06066931 - Reconstruction of the Pelvic Floor and Perineal Wound After Rectal ELAPE | Biotech Hunter | Biotech Hunter