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Drain or no drain? landmark trial settles debate after rectal cancer surgery

NCT ID NCT01269567

Disease control Sponsor: University Hospital, Bordeaux 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This study tested whether placing a temporary drain in the pelvis after rectal cancer surgery reduces the risk of serious infections like leaks or abscesses. About 500 patients were randomly assigned to receive a drain or not. The main goal was to see if drainage lowered pelvic sepsis within 30 days after surgery.

What this could mean

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

Active substance
pelvic drain (a tube placed during surgery to collect fluid)
What this could lead to
If successful, this could confirm that routine drainage after rectal cancer surgery reduces dangerous pelvic infections, improving recovery.
What could go wrong
This trial is completed, but results may not apply to all patients or hospitals. Drains can cause discomfort or rare complications.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

494 people

The number who actually took part.

Start date

Jan 2011

Finished

Jan 2015

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 years and older

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: * Rectal adenocarcinoma, histopathologically proved, with or without neoadjuvant treatment * Stapler or manual infraperitoneal anastomosis * With or without stoma * With bowel preparation * Open or laparoscopic approach * Stage T1-T4 Nx Mx * Age 18 years old or older * Information of the patient and signature of informed consent * Affiliation to a regime of social insurance Exclusion Criteria: * Colonic cancer (\> 15 cm from anal verge) * Abdominoperineal resection * Associated resection (prostate, seminal bladder, vagina…) * Simultaneous liver resection * Total coloproctectomy * Emergency * Infected rectal tumour * Pregnant women, suitable to be, or current suckling * Persons deprived of freedom or under guardianship * Persons under protection of justice * Impossibility to accept the medical follow-up of the study for geographic , social or psychic reasons.

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Conditions

The condition(s) this trial relates to.

colorectal neoplasm Digestive System Diseases digestive system disorder digestive system neoplasm Digestive System Neoplasms intestinal cancer intestinal disorder Neoplasms by Site rectal disorder rectum adenocarcinoma

As listed by the trial registrant

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

Multicenter study Pelvic drainage Randomized clinical trial Rectal cancer surgery

Contacts and locations

Locations

  • APHP- Saint Joseph

    Paris, 75014, France

  • APHP-Kremlin Bicetre

    Le Kremlin-Bicêtre, 94275, France

  • CH de BEAUVAIS

    Beauvais, 60021, France

  • CHRU Lille

    Lille, 59037, France

  • CHRU de Strasbourg

    Strasbourg, 67000, France

  • CHU Poitiers

    Poitiers, France

  • CHU d'AMIENS

    Amiens, 80054, France

  • Centre Hospitalier Lyon Sud

    Lyon, 69495, France

  • Département de Chirurgie Oncologique - CRLC Val d'Aurelle

    Montpellier, 34298, France

  • Département de Chirurgie Oncologique - Centre Oscar Lambret

    Lille, 59020, France

  • Département de Chirurgie Oncologique - Institut Paoli Calmette

    Marseille, 13009, France

  • Service de Chirurgie Digestive - CHU Charles Nicolle

    Rouen, 76031, France

  • Service de Chirurgie Digestive - CHU de Nantes - Hôtel Dieu

    Nantes, 44093, France

  • Service de Chirurgie Digestive - Hôpital A. Michallon

    La Tronche, 38700, France

  • Service de Chirurgie Digestive - Hôpital Purpan - Pavillon Dieulafoy

    Toulouse, 31059, France

  • Service de Chirurgie Digestive - Hôpital Saint-André - CHU de Bordeaux

    Bordeaux, 33075, France

  • Service de Chirurgie Digestive - Hôpital des Diaconnesses - La Croix Saint-Simon

    Paris, 75020, France

  • Service de Chirurgie Digestive et Générale - Brabois

    Vandœuvre-lès-Nancy, 54511, France

  • Service de Chirurgie Digestive et Viscérale - CHU Timone

    Marseille, 13385, France

  • Service de Chirurgie Générale et Digestive - Hôpital Beaujon

    Clichy, 92110, France

  • Service de Chirurgie Générale et Digestive - Hôpital Saint-Antoine

    Paris, 75012, France

  • Service de Chirurgie Viscérale - CHU Pontchaillou

    Rennes, 35033, France

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