Clinical trial NCT04248634: Evaluation of Delayed Coloanal Anastomosis
Official title: Short and Midterm Results of Delayed Colo-anal Anastomosis After Rectal Resection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Neoplasms
Keywords: Rectal neoplasmdelayed coloanal anastomosis
Ileostomy
Delayed coloanal anastomosis
Lead sponsor: Institut National d'Oncologie, Morocco
Sponsor class: OTHER_GOV
First posted: 2020-01-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Stoma rate at 90 days
timeFrame: 90 days
measure: Perineal complications
timeFrame: 90 days
Secondary outcomes:
measure: Clavien-Dindo complications
timeFrame: 90 days
measure: Functional outcomes
timeFrame: 12 months
measure: Quality of life assessement: EORTC QLQ30 score
timeFrame: 12 months
Other outcomes:
Locations:
city: Rabat
country: Morocco
facility: Institut National d'Oncologie
Study officials:
References: