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Completed

NCT Number: NCT04248634

Evaluation of Delayed Coloanal Anastomosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut National d'Oncologie

Rabat, 10100, Morocco

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

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.

Primary outcomes

  1. Stoma rate at 90 days

    Time frame: 90 days

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

  2. Perineal complications

    Time frame: 90 days

    Rates of perineal complications at 90 days after surgery

Secondary outcomes

  1. Clavien-Dindo complications

    Time frame: 90 days

    Rate of complications according to Clavien-Dindo grading

  2. Functional outcomes

    Time frame: 12 months

    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

  3. Quality of life assessement: EORTC QLQ30 score

    Time frame: 12 months

    Quality of life using the EORTC QLQ30 score at 6 and 12 months

Sponsors and collaborators

Lead sponsor

Institut National d'Oncologie, Morocco

Other Gov

Registry information

Official study title

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

Acronym: ACAD

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 30, 2020
Registry last updated
Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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