Evaluation of Delayed Coloanal Anastomosis

NCT ID: NCT04248634

Last Updated: 2020-02-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2019-12-31

Brief 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.

Detailed 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.

Conditions

Rectal Neoplasms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Adult patients> 18 years old.
• Rectal resection with the creation of a delayed colo-anal anastomosis.

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut National d'Oncologie, Morocco

OTHER_GOV

Sponsor Role: lead

Responsible Party

Anass Majbar

Professor of surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Institut National d'Oncologie

Rabat, , Morocco

Countries

Morocco

Other Identifiers

SCOD 1

Identifier Type: -

Identifier Source: org_study_id