Rectal Cancer SurgeryPhase 3GRECCAR 5NCT01269567
Drainage After Rectal Excision for Rectal Cancer
A Phase 3 study testing Laying and management of the drain (strictly randomized arm with drainage) and No pelvic drainage in people with Rectal Cancer Surgery and Randomized Clinical Trial, run by University Hospital, Bordeaux at 22 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer Surgery, Randomized Clinical Trial, Multicenter Study
- What is being tested?
- Laying and management of the drain (strictly randomized arm with drainage) and No pelvic drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 494 participants
- Where
- 22 sitesFrance
- Study dates
- Jan 2011to Jan 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Age 18 years old or older
- Information of the patient and signature of informed consent
- Affiliation to a regime of social insurance
Who cannot join
- Colonic cancer (> 15 cm from anal verge)
- Abdominoperineal resection
- Associated resection (prostate, seminal bladder, vagina…)
- Simultaneous liver resection
- Total coloproctectomy
- Emergency
Show all 11Show fewer
- 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.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
France22 sites
CHU d'AMIENS
Amiens, 80054
CH de BEAUVAIS
Beauvais, 60021
Service de Chirurgie Digestive - Hôpital Saint-André - CHU de Bordeaux
Bordeaux, 33075
Service de Chirurgie Générale et Digestive - Hôpital Beaujon
Clichy, 92110
Service de Chirurgie Digestive - Hôpital A. Michallon
La Tronche, 38700
APHP-Kremlin Bicetre
Le Kremlin-Bicêtre, 94275
Département de Chirurgie Oncologique - Centre Oscar Lambret
Lille, 59020
CHRU Lille
Lille, 59037
Centre Hospitalier Lyon Sud
Lyon, 69495
Département de Chirurgie Oncologique - Institut Paoli Calmette
Marseille, 13009
Service de Chirurgie Digestive et Viscérale - CHU Timone
Marseille, 13385
Département de Chirurgie Oncologique - CRLC Val d'Aurelle
Montpellier, 34298
Service de Chirurgie Digestive - CHU de Nantes - Hôtel Dieu
Nantes, 44093
Service de Chirurgie Générale et Digestive - Hôpital Saint-Antoine
Paris, 75012
APHP- Saint Joseph
Paris, 75014
Service de Chirurgie Digestive - Hôpital des Diaconnesses - La Croix Saint-Simon
Paris, 75020
CHU Poitiers
Poitiers
Service de Chirurgie Viscérale - CHU Pontchaillou
Rennes, 35033
Service de Chirurgie Digestive - CHU Charles Nicolle
Rouen, 76031
CHRU de Strasbourg
Strasbourg, 67000
Service de Chirurgie Digestive - Hôpital Purpan - Pavillon Dieulafoy
Toulouse, 31059
Service de Chirurgie Digestive et Générale - Brabois
Vandœuvre-lès-Nancy, 54511
About this study
Official title: 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)
Read the 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.
- Being tested
- Laying and management of the drain (strictly randomized arm with drainage), No pelvic drainage
- Keywords
- RectalNeoplasms, Colorectal Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Digestive System Diseases, Gastrointestinal Diseases, Intestinal Diseases, Rectal Diseases
- Medical subject headings
- Colorectal Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Digestive System Diseases, Gastrointestinal Diseases, Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laying and management of the drain (strictly randomized arm with drainage)Procedure or surgery
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.
No pelvic drainageProcedure or surgery
no aspiration drain at the end of intervention
| Study group | Role | What they receive |
|---|---|---|
| Drainage | Active comparator | Rectal excision with aspiration pelvic drainage Receives: Procedure: Laying and management of the drain (strictly randomized arm with drainage) |
| No drainage | Experimental | Rectal excision without aspiration pelvic drainage Receives: Procedure: No pelvic drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic sepsis
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.
Measured: within the first 30 days after surgery
Secondary outcomes (5)
Overall sepsis
Overall sepsis until 30 days (pelvic sepsis, wound abscess, urinary infection, pneumopathy, blood-poisoning)
Measured: up to 30 days after surgery
Peri-operative mortality
Peri-operative mortality (hospital mortality and/or until 30 days after surgery if the patient is already going out of hospital)
Measured: up to 30 days after surgery
Surgical morbidity according to Dindo classification
Surgical morbidity according to Dindo classification
Measured: within the first 6 months after surgery
Re-surgery during the hospitalization
Measured: during the hospitalization
Rate of closure of stoma
Rate of closure of stoma at 6 months
Measured: within the first 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rectal Cancer SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 494 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adélaïde Doussau, Dr, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269567
- Sponsor's protocol ID
- CHUBX 2010/24
- Other IDs
- 2010-A00868-31
- Acronym
- GRECCAR 5
- Status last verified
- Jul 2015
- First submitted
- 3 Jan 2011
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Denost Q, Rouanet P, Faucheron JL, Panis Y, Meunier B, Cotte E, Meurette G, Kirzin S, Sabbagh C, Loriau J, Benoist S, Mariette C, Sielezneff I, Lelong B, Mauvais F, Romain B, Barussaud ML, Germain C, Picat MQ, Rullier E, Laurent C; French Research Group of Rectal Cancer Surgery (GRECCAR). To Drain or Not to Drain Infraperitoneal Anastomosis After Rectal Excision for Cancer: The GRECCAR 5 Randomized Trial. Ann Surg. 2017 Mar;265(3):474-480. doi: 10.1097/SLA.0000000000001991.
PubMed 276317762017 European Society of Coloproctology (ESCP) collaborating group. Safety of primary anastomosis following emergency left sided colorectal resection: an international, multi-centre prospective audit. Colorectal Dis. 2018 Sep;20 Suppl 6:47-57. doi: 10.1111/codi.14373.
PubMed 30255647
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Drainage Versus no Drainage Following Rectal Excision With Low Anastomosis for Rectal Cancer
- ClinicalTrials.gov ID
- NCT01269567
- Acronym / sponsor ID
- GRECCAR 5 / CHUBX 2010/24
- Keywords
- RectalNeoplasms, Colorectal Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Digestive System Diseases, Gastrointestinal Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 494 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 4 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drainage | Active comparator | Procedure: Laying and management of the drain (strictly randomized arm with drainage)Rectal excision with aspiration pelvic drainage |
| No drainage | Experimental | Procedure: No pelvic drainageRectal excision without aspiration pelvic drainage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- Colonic cancer (> 15 cm from anal verge)
- Abdominoperineal resection
- Associated resection (prostate, seminal bladder, vagina…)
- Simultaneous liver resection
- Total coloproctectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Drainage |
| No pelvic drainageno aspiration drain at the end of intervention | Procedure or surgery | No drainage |
Primary outcome
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.
5 secondary outcomes
Overall sepsis
Time frame: up to 30 days after surgery
Peri-operative mortality
Time frame: up to 30 days after surgery
Surgical morbidity according to Dindo classification
Time frame: within the first 6 months after surgery
Re-surgery during the hospitalization
Time frame: during the hospitalization
Rate of closure of stoma
Time frame: within the first 6 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Results publication: PubMed 27631776Denost Q, Rouanet P, Faucheron JL, Panis Y, Meunier B, Cotte E, Meurette G, Kirzin S, Sabbagh C, Loriau J, Benoist S, Mariette C, Sielezneff I, Lelong B, Mauvais F, Romain B, Barussaud ML, Germain C, Picat MQ, Rullier E, Laurent C; French Research Group of Rectal Cancer Surgery (GRECCAR). To Drain or Not to Drain Infraperitoneal Anastomosis After Rectal Excision for Cancer: The GRECCAR 5 Randomized Trial. Ann Surg. 2017 Mar;265(3):474-480. doi: 10.1097/SLA.0000000000001991.
- Results publication: PubMed 302556472017 European Society of Coloproctology (ESCP) collaborating group. Safety of primary anastomosis following emergency left sided colorectal resection: an international, multi-centre prospective audit. Colorectal Dis. 2018 Sep;20 Suppl 6:47-57. doi: 10.1111/codi.14373.
Related trials for Rectal Cancer Surgery
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
RecruitingObservational study
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
Colorectal Neoplasms, Gastric Neoplasms
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
Not yet recruiting
T1 Colorectal Cancer After Local Excision: Decision Between Surgery and Active Surveillance (T1LDA Trial)
Colorectal Cancer
RecruitingPhase 2
Brachytherapy Followed by Nivolumab Prior to Surgery in Rectal Cancer
Locally Advanced Rectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adélaïde Doussau, Dr study chair
University Hospital, Bordeaux
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Laying and management of the drain (strictly randomized arm with drainage) and No pelvic drainage in people with Rectal Cancer Surgery and Randomized Clinical Trial, run by University Hospital, Bordeaux at 22 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic sepsis (time frame: within the first 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01269567, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.