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

August 31, 2020 updated by: Amine Souadka, Moroccan Society of Surgery

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Morocco
      • Rabat, Morocco
        • National Institut of Oncology, Surgical oncology department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
180 days from surgery
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
180 days from surgery
Globcal Quality of life of patients with PCPC and PLIC
Time Frame: 180 days from surgery
using the EORTC C30 Quality Of Life questionnaires
180 days from surgery
Specific Quality of life of patients with PCPC and PLIC
Time Frame: 180 days from surgery
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
Time Frame: 90 days from surgery
defined by the Clavien Dindo rated from I to V at 90 post operative day.
90 days from surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Moroccan Society of Surgery

Collaborators

Institut National d'Oncologie Sidi Mohammed Ben Abdellah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

October 20, 2019

First Submitted That Met QC Criteria

October 25, 2019

First Posted (Actual)

October 28, 2019

Study Record Updates

Last Update Posted (Actual)

September 1, 2020

Last Update Submitted That Met QC Criteria

August 31, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCPC_PLIC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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