Drainage After Rectal Excision for Rectal Cancer
GRECCAR 5
Randomized Trial Comparing Drainage Versus no Drainage Following Rectal Excision With Low Anastomosis for Rectal Cancer
1 other identifier
interventional
494
1 country
22
Brief 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. 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2011
Typical duration for phase_3
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 3, 2011
CompletedFirst Posted
Study publicly available on registry
January 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedJuly 23, 2015
July 1, 2015
4 years
January 3, 2011
July 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
within the first 30 days after surgery
Secondary Outcomes (5)
Overall sepsis
up to 30 days after surgery
Peri-operative mortality
up to 30 days after surgery
Surgical morbidity according to Dindo classification
within the first 6 months after surgery
Re-surgery during the hospitalization
during the hospitalization
Rate of closure of stoma
within the first 6 months after surgery
Study Arms (2)
Drainage
ACTIVE COMPARATORRectal excision with aspiration pelvic drainage
No drainage
EXPERIMENTALRectal excision without aspiration pelvic drainage
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
CHU d'AMIENS
Amiens, 80054, France
CH de BEAUVAIS
Beauvais, 60021, France
Service de Chirurgie Digestive - Hôpital Saint-André - CHU de Bordeaux
Bordeaux, 33075, France
Service de Chirurgie Générale et Digestive - Hôpital Beaujon
Clichy, 92110, France
Service de Chirurgie Digestive - Hôpital A. Michallon
La Tronche, 38700, France
APHP-Kremlin Bicetre
Le Kremlin-Bicêtre, 94275, France
Département de Chirurgie Oncologique - Centre Oscar Lambret
Lille, 59020, France
CHRU Lille
Lille, 59037, France
Centre Hospitalier Lyon Sud
Lyon, 69495, France
Département de Chirurgie Oncologique - Institut Paoli Calmette
Marseille, 13009, France
Service de Chirurgie Digestive et Viscérale - CHU Timone
Marseille, 13385, France
Département de Chirurgie Oncologique - CRLC Val d'Aurelle
Montpellier, 34298, France
Service de Chirurgie Digestive - CHU de Nantes - Hôtel Dieu
Nantes, 44093, France
Service de Chirurgie Générale et Digestive - Hôpital Saint-Antoine
Paris, 75012, France
APHP- Saint Joseph
Paris, 75014, France
Service de Chirurgie Digestive - Hôpital des Diaconnesses - La Croix Saint-Simon
Paris, 75020, France
CHU Poitiers
Poitiers, France
Service de Chirurgie Viscérale - CHU Pontchaillou
Rennes, 35033, France
Service de Chirurgie Digestive - CHU Charles Nicolle
Rouen, 76031, France
CHRU de Strasbourg
Strasbourg, 67000, France
Service de Chirurgie Digestive - Hôpital Purpan - Pavillon Dieulafoy
Toulouse, 31059, France
Service de Chirurgie Digestive et Générale - Brabois
Vandœuvre-lès-Nancy, 54511, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Adélaïde Doussau, Dr
University Hospital, Bordeaux
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2011
First Posted
January 4, 2011
Study Start
January 1, 2011
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
July 23, 2015
Record last verified: 2015-07