Evaluation of Delayed Coloanal Anastomosis

NCT04248634 | Completed

• 1 other identifier: SCOD 1
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Neoplasms

Keywords

Rectal neoplasmdelayed coloanal anastomosis; Ileostomy; Delayed coloanal anastomosis

Outcome Measures

Primary Outcomes (2)

• Stoma rate at 90 days

  The rate of patients who required a stoma creation at 90 days

  90 days

• Perineal complications

  Rates of perineal complications at 90 days after surgery

  90 days

Secondary Outcomes (3)

• Clavien-Dindo complications

  90 days

• Functional outcomes

  12 months

• Quality of life assessement: EORTC QLQ30 score

  12 months

Interventions

Delayed colo-anal anastomosis PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All consecutive patients aged above 18 years, who undergo rectal resection with the creation of delayed colo-anal anastomosis.

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Institut National d'Oncologie, Morocco: lead

Study Sites (1)

Institut National d'Oncologie

Rabat, 10100, Morocco

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of surgery

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: January 30, 2020
• Study Start: January 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 20, 2020

Record last verified: 2020-02

Locations

MO (1)