Clinical trial NCT04141566: Pseudo Continent Perineal Colostomy vs Permanent Left Iliac Colostomy After Abdominoperineal Resection for Ultra Low Rectal Adenocarcinoma
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Neoplasms
Colostomy Stoma
Quality of Life
Keywords: Pseudocontinent perineal colostomy
Abdominoperineal resection
colostomy
Cost effectiveness
quality of life
Lead sponsor: Moroccan Society of Surgery
Sponsor class: OTHER
Collaborators: name: Institut National d'Oncologie Sidi Mohammed Ben Abdellah
First posted: 2019-10-28
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent an abdominoperineal resection for ultra low rectal cancer with the creation of a definitive iliac colostomy or a pseudo continent perineal colostomy.

The following informations will be collected : age, gender, type of stoma,operative aspects, postoperative morbidity according to Clavien score, out of pocket costs and out of pocket hospital bills, quality of life at 6 months after surgery according to EORTC 30 and CR29 QOL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cost of management of both stoma types
timeFrame: 180 days from surgery
measure: Costs of hospital stay
timeFrame: 180 days from surgery
measure: Globcal Quality of life of patients with PCPC and PLIC
timeFrame: 180 days from surgery
measure: Specific Quality of life of patients with PCPC and PLIC
timeFrame: 180 days from surgery
Secondary outcomes:
measure: 90 day morbidity and mortality rate
timeFrame: 90 days from surgery
Other outcomes:
Locations:
city: Rabat
country: Morocco
facility: National Institut of Oncology, Surgical oncology department
Study officials:
References:
citation: Souadka A, Majbar MA, Amrani L, Souadka A. Perineal pseudocontinent colostomy for ultra-low rectal adenocarcinoma: the muscular graft as a pseudosphincter. Acta Chir Belg. 2016 Oct;116(5):278-281. doi: 10.1080/00015458.2016.1174020. Epub 2016 Jul 29.
citation: Souadka A, Majbar MA, El Harroudi T, Benkabbou A, Souadka A. Perineal pseudocontinent colostomy is safe and efficient technique for perineal reconstruction after abdominoperineal resection for rectal adenocarcinoma. BMC Surg. 2015 Apr 10;15:40. doi: 10.1186/s12893-015-0027-z.
citation: Souadka A, Majbar MA, Bougutab A, El Othmany A, Jalil A, Ahyoud FZ, El Malki HO, Souadka A. Risk factors of poor functional results at 1-year after pseudocontinent perineal colostomy for ultralow rectal adenocarcinoma. Dis Colon Rectum. 2013 Oct;56(10):1143-8. doi: 10.1097/DCR.0b013e31829f8cd5.
citation: Dumont F, Souadka A, Goere D, Lasser P, Elias D. Impact of perineal pseudocontinent colostomy on perineal wound healing after abdominoperineal resection. J Surg Oncol. 2012 Jun 1;105(7):628-31. doi: 10.1002/jso.22105. Epub 2011 Sep 22.
citation: Dumont F, Ayadi M, Goere D, Honore C, Elias D. Comparison of fecal continence and quality of life between intersphincteric resection and abdominoperineal resection plus perineal colostomy for ultra-low rectal cancer. J Surg Oncol. 2013 Sep;108(4):225-9. doi: 10.1002/jso.23379. Epub 2013 Jul 19.