Colostomy Stoma, Quality of Life, Rectal Neoplasms
Conditions
Keywords
Pseudocontinent perineal colostomy, Abdominoperineal resection, colostomy, Cost effectiveness, quality of life
Brief 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.
Interventions
PROCEDUREPerineal 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.
PROCEDUREPermanent left iliac colostomy
After a usual laparoscopic APR, the perineal wound is closed and a permanent left iliac colostomy is performed
Sponsors
Institut National d'Oncologie Sidi Mohammed Ben Abdellah
Moroccan Society of Surgery
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cost of management of both stoma types | 180 days from surgery | defined by out of pocket costs during the first 6 months following the surgery in euros |
| Costs of hospital stay | 180 days from surgery | defined as Out of pocket hospital bills in euros for all of the admission and the readmissions for surgical complication management |
| Globcal Quality of life of patients with PCPC and PLIC | 180 days from surgery | using the EORTC C30 Quality Of Life questionnaires |
| Specific Quality of life of patients with PCPC and PLIC | 180 days from surgery | using the EORTC CR29 Quality Of Life questionnaires |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 90 day morbidity and mortality rate | 90 days from surgery | defined by the Clavien Dindo rated from I to V at 90 post operative day. |
Countries
Morocco
Outcome results
None listed