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

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04141566
• Other study ID #: PCPC_PLIC
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: August 2020
• Source: Moroccan Society of Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Colostomy Stoma
• Quality of Life
• Rectal Neoplasms

Intervention

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.
• Permanent left iliac colostomy
After a usual laparoscopic APR, the perineal wound is closed and a permanent left iliac colostomy is performed

Locations

Country	Name	City	State
Morocco	National Institut of Oncology, Surgical oncology department	Rabat

Sponsors (2)

Lead Sponsor	Collaborator
Moroccan Society of Surgery	Institut National d'Oncologie Sidi Mohammed Ben Abdellah

Country where clinical trial is conducted

Morocco, 

References & Publications (5)

Dumont F, Ayadi M, Goéré D, Honoré 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. — View Citation

Dumont F, Souadka A, Goéré 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Globcal Quality of life of patients with PCPC and PLIC	using the EORTC C30 Quality Of Life questionnaires	180 days from surgery
Primary	Specific Quality of life of patients with PCPC and PLIC	using the EORTC CR29 Quality Of Life questionnaires	180 days from surgery
Secondary	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