Drainage After Rectal Excision for Rectal Cancer (GRECCAR 5)

May 11, 2026 updated by: University Hospital, Bordeaux

Randomized Trial Comparing Drainage Versus no Drainage Following Rectal Excision With Low Anastomosis for Rectal Cancer

After rectal excision, the rate of anastomotic leak and abscess is higher than after colic surgery. In order to limit and avoid the risk of pelvic sepsis after rectal excision, a prophylactic pelvic drainage is usually used. If current data have confirmed the uselessness of drainage in colic surgery, the question stay in abeyance in rectal surgery. This practice had never been evaluated in patients with rectal excision and low anastomosis (patients with a high risk of pelvic sepsis)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After rectal excision, the rate of anastomotic leak and abscess is higher than after colic surgery. In order to limit and avoid the risk of pelvic sepsis after rectal excision, a prophylactic pelvic drainage is usually used. If current data have confirmed the uselessness of drainage in colic surgery, the question stay in abeyance in rectal surgery. This practice had never been evaluated in patients with rectal excision and low anastomosis (patients with a high risk of pelvic sepsis) The aim of the study is to assess the impact of pelvic drainage vs. non pelvic drainage on risk of pelvic sepsis after rectal excision for cancer with infraperitoneal anastomosis. The principal objective is to compare the rate of pelvic sepsis until 30 days between the 2 groups of patients who had a rectal excision with and without pelvic drainage. It is a randomized clinical trial of superiority, multicentric, without blinding, in 2 parallel groups with ratio (1:1): distribution of the number of patients in the groups.

Study Type

Interventional

Enrollment (Actual)

494

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • CHU d'Amiens
      • Beauvais, France, 60021
        • CH de BEAUVAIS
      • Bordeaux, France, 33075
        • Service de Chirurgie Digestive - Hôpital Saint-André - CHU de Bordeaux
      • Clichy, France, 92110
        • Service de Chirurgie Générale et Digestive - Hôpital Beaujon
      • La Tronche, France, 38700
        • Service de Chirurgie Digestive - Hôpital A. Michallon
      • Le Kremlin-Bicêtre, France, 94275
        • APHP-Kremlin Bicetre
      • Lille, France, 59037
        • CHRU Lille
      • Lille, France, 59020
        • Département de Chirurgie Oncologique - Centre Oscar Lambret
      • Lyon, France, 69495
        • Centre Hospitalier Lyon Sud
      • Marseille, France, 13009
        • Département de Chirurgie Oncologique - Institut Paoli Calmette
      • Marseille, France, 13385
        • Service de Chirurgie Digestive et Viscérale - CHU Timone
      • Montpellier, France, 34298
        • Département de Chirurgie Oncologique - CRLC Val d'Aurelle
      • Nantes, France, 44093
        • Service de Chirurgie Digestive - CHU de Nantes - Hôtel Dieu
      • Paris, France, 75012
        • Service de Chirurgie Générale et Digestive - Hôpital Saint-Antoine
      • Paris, France, 75014
        • APHP- Saint Joseph
      • Paris, France, 75020
        • Service de Chirurgie Digestive - Hôpital des Diaconnesses - La Croix Saint-Simon
      • Poitiers, France
        • CHU Poitiers
      • Rennes, France, 35033
        • Service de Chirurgie Viscérale - CHU Pontchaillou
      • Rouen, France, 76031
        • Service de Chirurgie Digestive - CHU Charles Nicolle
      • Strasbourg, France, 67000
        • CHRU de Strasbourg
      • Toulouse, France, 31059
        • Service de Chirurgie Digestive - Hôpital Purpan - Pavillon Dieulafoy
      • Vandœuvre-lès-Nancy, France, 54511
        • Service de Chirurgie Digestive et Générale - Brabois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Drainage
Rectal excision with aspiration pelvic drainage
Procedure: Laying and management of the drain (strictly randomized arm with drainage)
At the end of intervention, the surgeon will position an aspiration drain in order to permit a postoperative pelvic drainage. The drain will be positioned forward sacrum, behind anastomosis. The drain will be leaved in place between 3 and 5 days. The criteria of drain ablation are the absence of haemorrhagic liquid and/or un daily debit < 100ml. Nursing care will be daily with change of bottle for collect pelvic serosity, accounting of quantity of collected liquid and realization of a dried bandage through contact with penetration of the drain.
Experimental: No drainage
Rectal excision without aspiration pelvic drainage
Procedure: No pelvic drainage
no aspiration drain at the end of intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pelvic sepsis
Time Frame: within the first 30 days after surgery
Pelvic sepsis until 30 days after rectal excision is the primary end point. It is defined as the occurrence of an anastomotic leak revealed by peritonitis or discharge of gas, stools or pus, the vagina or the abdominal wound, and/or a pelvic abscess, between J0 and J30.
within the first 30 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall sepsis
Time Frame: up to 30 days after surgery
Overall sepsis until 30 days (pelvic sepsis, wound abscess, urinary infection, pneumopathy, blood-poisoning)
up to 30 days after surgery
Peri-operative mortality
Time Frame: up to 30 days after surgery
Peri-operative mortality (hospital mortality and/or until 30 days after surgery if the patient is already going out of hospital)
up to 30 days after surgery
Surgical morbidity according to Dindo classification
Time Frame: within the first 6 months after surgery
Surgical morbidity according to Dindo classification
within the first 6 months after surgery
Re-surgery during the hospitalization
Time Frame: during the hospitalization
during the hospitalization
Rate of closure of stoma
Time Frame: within the first 6 months after surgery
Rate of closure of stoma at 6 months
within the first 6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Study Chair: Adélaïde DOUSSAU, Dr, University Hospital, Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

January 3, 2011

First Submitted That Met QC Criteria

January 3, 2011

First Posted (Estimated)

January 4, 2011

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2010/24
  • 2010-A00868-31 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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