Evaluation of Delayed Coloanal Anastomosis

Rectal Neoplasms Clinical Trial

— ACAD  

Official title:

Short and Midterm Results of Delayed Colo-anal Anastomosis After Rectal Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04248634
• Other study ID #: SCOD 1
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Rectal Neoplasms

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