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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Rectal Neoplasms, Colostomy Stoma, Quality of Life

Intervention / Treatment
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* Procedure: Perineal pseudocontinent colostomy
* Procedure: Permanent left iliac colostomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of 18 years old or above Abdominoperineal resection for ultra low rectal cancer Creation of a definitive iliac colostomy or a pseudo continent perineal colostomy Patients willing to participate to this study (writting consent) Exclusion Criteria: -Patients unable to respond to the Quality Of Life questionnaires

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PCPC<br>pseudocontinent perineal colostomy using shmidt technique for perineal reconstruction after abdominoperineal resection | Procedure: Perineal pseudocontinent colostomy<br>* 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.<br>|
| PLIC<br>Permanenet left iliac colostomy , the standard technique after abdominoperineal resection and primary closure of the perineal wound | Procedure: Permanent left iliac colostomy<br>* After a usual laparoscopic APR, the perineal wound is closed and a permanent left iliac colostomy is performed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost of management of both stoma types | defined by out of pocket costs during the first 6 months following the surgery in euros | 180 days from surgery | 
| Costs of hospital stay | defined as Out of pocket hospital bills in euros for all of the admission and the readmissions for surgical complication management | 180 days from surgery | 
| Globcal Quality of life of patients with PCPC and PLIC | using the EORTC C30 Quality Of Life questionnaires | 180 days from surgery | 
| Specific Quality of life of patients with PCPC and PLIC | using the EORTC CR29 Quality Of Life questionnaires | 180 days from surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90 day morbidity and mortality rate | defined by the Clavien Dindo rated from I to V at 90 post operative day. | 90 days from surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pseudocontinent perineal colostomy, Abdominoperineal resection, colostomy, Cost effectiveness, quality of life