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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04248634
Other study ID # SCOD 1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date December 31, 2019

Study information

Verified date February 2020
Source Institut National d'Oncologie, Morocco
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

After rectal resection for cancer of the lower rectum, the restoration of continuity is done by a colo-anal anastomosis with a protective ileostomy. However, the ileostomy is very little accepted by patients. It is associated with significant morbidity and a deterioration in the quality of life.

Delayed colo-anal anastomosis has been proposed as an alternative to direct colo-anal anastomosis with a protective ileostomy. The theoretical advantage of this technique is to reduce the risk of anastomotic leaks and to avoid ileostomy.

In this study, the investigators will retrospectively evaluate the short and midterm results of this technique.


Description:

After rectal resection for cancer of the lower rectum, the restoration of continuity is done by a colo-anal anastomosis with a protective ileostomy. The latter reduces the risk and severity of clinical anastomotic fistulas. However, the ileostomy is very little accepted by patients. It is associated with significant morbidity reaching up to 30% of patients, a deterioration in the quality of life and the need for a second surgery to restore digestive continuity. And specifically in low-income countries, ostomy bags are expensive and are not reimbursed, and therefore constitute a heavy burden for Moroccan patients.

In order to overcome these drawbacks, delayed colo-anal anastomosis has been proposed as an alternative to direct colo-anal anastomosis with a protective ileostomy. This technique consists of externalizing the colon in the first stage by the transanal route, without creating an ileostomy, and waiting a week for the creation of the anastomosis. The theoretical advantage of this technique is to reduce the risk of anastomotic leaks and to avoid ileostomy. Several studies have shown encouraging results in the short and midterm, and it is listed among the technical options in the French recommendations for the management of rectal cancer.

In this study, the investigators will retrospectively evaluate the short and midterm results of this technique.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult patients> 18 years old.

- Rectal resection with the creation of a delayed colo-anal anastomosis.

Exclusion Criteria:

- None

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Delayed colo-anal anastomosis
Colo-anal anastomosis performed in two surgical steps: - Step one: the colon is exteriorized transanally and 5 cm of the colon is left outside without anastomosis creation. Step two: after 7 days, the excess colon is resected and the colo-anal anastomosis is created.

Locations

Country Name City State
Morocco Institut National d'Oncologie Rabat

Sponsors (1)

Lead Sponsor Collaborator
Institut National d'Oncologie, Morocco

Country where clinical trial is conducted

Morocco, 

Outcome

Type Measure Description Time frame Safety issue
Primary Stoma rate at 90 days The rate of patients who required a stoma creation at 90 days 90 days
Primary Perineal complications Rates of perineal complications at 90 days after surgery 90 days
Secondary Clavien-Dindo complications Rate of complications according to Clavien-Dindo grading 90 days
Secondary Functional outcomes Continence score according to the Low anterior resection syndrom score (LARS). Score from 0 to 42 (0-20 No LARS / 21-29 Minor LARS / 30-42 Major LARS). Higher score indicates worse outcome 12 months
Secondary Quality of life assessement: EORTC QLQ30 score Quality of life using the EORTC QLQ30 score at 6 and 12 months 12 months
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