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Completed

NCT Number: NCT04141566

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

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

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Key information

Conditions

Rectal Neoplasms Colorectal Neoplasms Colostomy Stoma Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Quality of Life Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institut of Oncology, Surgical oncology department

Rabat, Morocco

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Perineal pseudocontinent colostomy

Procedure

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

Procedure

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

Primary outcomes

  1. Cost of management of both stoma types

    Time frame: 180 days from surgery

    defined by out of pocket costs during the first 6 months following the surgery in euros

  2. Costs of hospital stay

    Time frame: 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

  3. Globcal Quality of life of patients with PCPC and PLIC

    Time frame: 180 days from surgery

    using the EORTC C30 Quality Of Life questionnaires

  4. Specific Quality of life of patients with PCPC and PLIC

    Time frame: 180 days from surgery

    using the EORTC CR29 Quality Of Life questionnaires

Secondary outcomes

  1. 90 day morbidity and mortality rate

    Time frame: 90 days from surgery

    defined by the Clavien Dindo rated from I to V at 90 post operative day.

Sponsors and collaborators

Lead sponsor

Moroccan Society of Surgery

Other

Collaborators

  • Institut National d'Oncologie Sidi Mohammed Ben Abdellah

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 28, 2019
Registry last updated
Sep 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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