NCT04141566

Pseudo Continent Perineal Colostomy vs Permanent Left Iliac Colostomy After Abdominoperineal Resection for Ultra Low Rectal Adenocarcinoma

Pseudo Continent Perineal Colostomy vs Permanent Left Iliac Colostomy After Abdominoperineal Resection for Ultra Low Rectal Adenocarcinoma: Comparaison of Out of Pocket Costs, Hospital Bills and Quality of Life

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 35 (actual)
• Sponsor: Moroccan Society of Surgery · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

Aim of this study is to compare the cost-effectiveness and the quality of life in the 6 months following the surgery of a pseudo continent perineal colostomy (PCPC) and a permanent left iliac colostomy (PLIC) following an abdominoperineal resection (APR) for ultra low rectal cancer

Detailed description

The surgical treatment of ultra low rectal adenocarcinoma has known great changes, yet the abdominoperineal resection (APR) is still indicated in over 20% of these cases. A permanent left abdominal stoma is the standard salvage technique. The pseudo continent perineal colostomy (PCPC) is an alternative technique especially in low income countries where the stoma bag and stoma care is not covered by health insurances. Furthermore, this technique allows the conservation of body image, which is frequently requested by muslim patients whenever it is possible. The aim of this study is to compare the cost effectiveness of both techniques as well as the quality of life of patients in the 6 first months following the surgery.

Conditions

• Rectal Neoplasms
• Colostomy Stoma
• Quality of Life

Interventions

Type	Name	Description
PROCEDURE	Perineal pseudocontinent colostomy	The procedure is performed in 2stages: as a usual APR starting by a laparoscopic approach esnsuring a complete mesorectal excision,then a perineal approach ensuring an extended excision of the entire internal and external sphincter complex, allowing the excision of the specimen. 8to10cm of tof the colon is resected and harvested as a free graft, stripped of its meso and epiploics , then from its mucosa and placed in an antibiotic solution for 10min. This graft is wrapped snugly around the end of the colon 2-3 cm from its distal end for 1 and a half round. Absorbable 3.0 Sutures are taken to hold it in place. The end of the colon is brought out as a stoma in the perineum. Colonic irrigations are started from the third day according to the protocol previously reported. Patients and one of their family members are daily educated and assisted while performing colonic irrigations by specialized nurses.
PROCEDURE	Permanent left iliac colostomy	After a usual laparoscopic APR, the perineal wound is closed and a permanent left iliac colostomy is performed

Timeline

• Start date: 2018-01-01
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2019-10-28
• Last updated: 2020-09-01

Locations

1 site across 1 country: Morocco