Drainage After Rectal Excision for Rectal Cancer (GRECCAR 5)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01269567
First received: January 3, 2011
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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)


Condition Intervention Phase
Rectal Cancer Surgery
Randomized Clinical Trial
Multicenter Study
Pelvic Drainage
Procedure: Laying and management of the drain (strictly randomized arm with drainage)
Procedure: No pelvic drainage
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized Trial Comparing Drainage Versus no Drainage Following Rectal Excision With Low Anastomosis for Rectal Cancer

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Pelvic sepsis [ Time Frame: within the first 30 days after surgery ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Overall sepsis [ Time Frame: up to 30 days after surgery ] [ Designated as safety issue: Yes ]
    Overall sepsis until 30 days (pelvic sepsis, wound abscess, urinary infection, pneumopathy, blood-poisoning)

  • Peri-operative mortality [ Time Frame: up to 30 days after surgery ] [ Designated as safety issue: Yes ]
    Peri-operative mortality (hospital mortality and/or until 30 days after surgery if the patient is already going out of hospital)

  • Surgical morbidity according to Dindo classification [ Time Frame: within the first 6 months after surgery ] [ Designated as safety issue: Yes ]
    Surgical morbidity according to Dindo classification

  • Re-surgery during the hospitalization [ Time Frame: during the hospitalization ] [ Designated as safety issue: Yes ]
  • Rate of closure of stoma [ Time Frame: within the first 6 months after surgery ] [ Designated as safety issue: Yes ]
    Rate of closure of stoma at 6 months


Estimated Enrollment: 466
Study Start Date: January 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01269567

Locations
France
CHU d'AMIENS
Amiens, France, 80054
CH de BEAUVAIS
Beauvais, France, 60021
Service de Chirurgie Digestive - Hôpital Saint-André - CHU de Bordeaux
Bordeaux, France, 33075
Service de Chirurgie Générale et Digestive - Hôtel Dieu - CHU de CLERMONT-FERRAND
Clermont-ferrand, France, 63000
Service de Chirurgie Générale et Digestive - Hôpital Beaujon
Clichy, France, 92110
Service de Chirurgie Digestive - Hôpital A. Michallon
La Tronche, France, 38700
APHP-Kremlin Bicetre
Le Kremlin-bicetre, France, 94275
Département de Chirurgie Oncologique - Centre Oscar Lambret
Lille, France, 59020
CHRU Lille
Lille, France, 59037
Centre Hospitalier Lyon Sud
Lyon, France, 69495
Service de Chirurgie Digestive et Viscérale - CHU Timone
Marseille, France, 13385
Département de Chirurgie Oncologique - Institut Paoli Calmette
Marseille, France, 13009
Département de Chirurgie Oncologique - CRLC Val d'Aurelle
Montpellier, France, 34298
Service de Chirurgie Digestive - CHU de Nantes - Hôtel Dieu
Nantes, France, 44093
Service de Chirurgie Générale et Digestive - Hôpital Saint-Antoine
Paris, France, 75012
APHP- Saint Joseph
Paris, France, 75014
Service de Chirurgie Digestive - Hôpital des Diaconnesses - La Croix Saint-Simon
Paris, France, 75020
Service de Chirurgie Viscérale - CHU Pontchaillou
Rennes, France, 35033
Service de Chirurgie Digestive - CHU Charles Nicolle
Rouen, France, 76031
CHRU de Strasbourg
Strasbourg, France, 67000
Service de Chirurgie Digestive - Hôpital Purpan - Pavillon Dieulafoy
Toulouse, France, 31059
Service de Chirurgie Digestive et Générale - Brabois
Vandoeuvre Les Nancy, France, 54511
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Study Chair: Adélaïde Doussau, Dr University Hospital, Bordeaux
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01269567     History of Changes
Other Study ID Numbers: CHUBX 2010/24
Study First Received: January 3, 2011
Last Updated: August 19, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
RectalNeoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 16, 2014