Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New surgery for rectal cancer could cut leak risk and stoma need

NCT ID NCT01876901

Disease control Sponsor: Institut Bergonié Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 2 trial tested a two-step surgical procedure called delayed coloanal anastomosis (2SCA) in 124 patients with medium or lower rectal cancer. The goal was to see if this technique lowers the rate of dangerous leaks at the surgical connection and reduces the need for a colostomy bag. Results showed that the procedure may be safer than the standard immediate anastomosis, with fewer leaks and fewer patients needing a stoma.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) - a surgical procedure
What this could lead to
If successful, this surgical technique could lower the risk of post-surgery leaks and reduce the need for temporary or permanent stomas in rectal cancer patients.
What could go wrong
This is a phase 2 trial with a relatively small sample size (124 patients). The results may not apply to all patients, and the procedure still carries surgical risks like infection or bleeding.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

124 people

The number who actually took part.

Started

Aug 2010

Finished

Feb 2019

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically proven rectal adenocarcinoma. * Medium or lower rectum tumour requiring removal of the entire rectum and its mesorectum. * T1 N+ or T2 N+ or T3 N+ or T3 N0 and M0 tumour. * Age between 18 and 75 years . * ASA ≤ 2. * Sphincter continence compatible with coloanal anastomosis. * Patients who received preoperative radiotherapy alone or chemotherapy and radiotherapy. * Patient affiliated to social security. * For patients of childbearing age, use of contraception. * Patient information and consent for study participation Exclusion Criteria: * Other histology of rectal cancer. * T1 N0 or T2 N0 or T4 tumour. * Metastatic disease M1. * History of cancer except cervix in situ carcinoma or skin basal cell carcinoma. * Patient with psychological, social, family or geographical reasons who couldn't be treated or monitored regularly by the criteria of the study * Patients deprived of liberty or under guardianship. * Pregnant or nursing women.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Medium and lower rectal cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

rectal cancer rectal neoplasm rectum adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Medium and lower rectal cancer

Contacts and locations

Locations

  • CHU DE BORDEAUX - Hôpital Saint André

    Bordeaux, Aquitaine, 33000, France

  • CHU de GRENOBLE

    Grenoble, Auvergne-Rhône-Alpes, 38000, France

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, Lorraine, 54000, France

  • Centre Léon Bérard

    Lyon, Auvergne-Rhône-Alpes, 69000, France

  • Chu de Nancy

    Nancy, Lorraine, 54000, France

  • Clinique Du Tonkin

    Villeurbanne, Auvergne-Rhône-Alpes, 69000, France

  • HOSPICES CIVILS DE LYON - Hôpital de la Croix Rousse

    Lyon, Auvergne-Rhône-Alpes, 69000, France

  • Institut Bergonié

    Bordeaux, Aquitaine, 33000, France

  • Institut Paoli Calmettes

    Marseille, Bouche Du Rhône, 13000, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.