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Drainage After Rectal Excision for Rectal Cancer (GRECCAR 5)

Primary Purpose

Rectal Cancer Surgery, Randomized Clinical Trial, Multicenter Study

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Laying and management of the drain (strictly randomized arm with drainage)
No pelvic drainage
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rectal Cancer Surgery focused on measuring RectalNeoplasms, Colorectal Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Digestive System Diseases, Gastrointestinal Diseases, Intestinal Diseases, Rectal Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU d'AMIENS
  • CH de BEAUVAIS
  • Service de Chirurgie Digestive - Hôpital Saint-André - CHU de Bordeaux
  • Service de Chirurgie Générale et Digestive - Hôpital Beaujon
  • Service de Chirurgie Digestive - Hôpital A. Michallon
  • APHP-Kremlin Bicetre
  • Département de Chirurgie Oncologique - Centre Oscar Lambret
  • CHRU Lille
  • Centre Hospitalier Lyon Sud
  • Département de Chirurgie Oncologique - Institut Paoli Calmette
  • Service de Chirurgie Digestive et Viscérale - CHU Timone
  • Département de Chirurgie Oncologique - CRLC Val d'Aurelle
  • Service de Chirurgie Digestive - CHU de Nantes - Hôtel Dieu
  • Service de Chirurgie Générale et Digestive - Hôpital Saint-Antoine
  • APHP- Saint Joseph
  • Service de Chirurgie Digestive - Hôpital des Diaconnesses - La Croix Saint-Simon
  • CHU Poitiers
  • Service de Chirurgie Viscérale - CHU Pontchaillou
  • Service de Chirurgie Digestive - CHU Charles Nicolle
  • CHRU de Strasbourg
  • Service de Chirurgie Digestive - Hôpital Purpan - Pavillon Dieulafoy
  • Service de Chirurgie Digestive et Générale - Brabois

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Drainage

No drainage

Arm Description

Rectal excision with aspiration pelvic drainage

Rectal excision without aspiration pelvic drainage

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall sepsis
Overall sepsis until 30 days (pelvic sepsis, wound abscess, urinary infection, pneumopathy, blood-poisoning)
Peri-operative mortality
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
Surgical morbidity according to Dindo classification
Re-surgery during the hospitalization
Rate of closure of stoma
Rate of closure of stoma at 6 months

Full Information

First Posted
January 3, 2011
Last Updated
July 22, 2015
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT01269567
Brief Title
Drainage After Rectal Excision for Rectal Cancer
Acronym
GRECCAR 5
Official Title
Randomized Trial Comparing Drainage Versus no Drainage Following Rectal Excision With Low Anastomosis for Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer Surgery, Randomized Clinical Trial, Multicenter Study, 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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
494 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drainage
Arm Type
Active Comparator
Arm Description
Rectal excision with aspiration pelvic drainage
Arm Title
No drainage
Arm Type
Experimental
Arm Description
Rectal excision without aspiration pelvic drainage
Intervention Type
Procedure
Intervention Name(s)
Laying and management of the drain (strictly randomized arm with drainage)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
No pelvic drainage
Intervention Description
no aspiration drain at the end of intervention
Primary Outcome Measure Information:
Title
Pelvic sepsis
Description
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.
Time Frame
within the first 30 days after surgery
Secondary Outcome Measure Information:
Title
Overall sepsis
Description
Overall sepsis until 30 days (pelvic sepsis, wound abscess, urinary infection, pneumopathy, blood-poisoning)
Time Frame
up to 30 days after surgery
Title
Peri-operative mortality
Description
Peri-operative mortality (hospital mortality and/or until 30 days after surgery if the patient is already going out of hospital)
Time Frame
up to 30 days after surgery
Title
Surgical morbidity according to Dindo classification
Description
Surgical morbidity according to Dindo classification
Time Frame
within the first 6 months after surgery
Title
Re-surgery during the hospitalization
Time Frame
during the hospitalization
Title
Rate of closure of stoma
Description
Rate of closure of stoma at 6 months
Time Frame
within the first 6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adélaïde Doussau, Dr
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Study Chair
Facility Information:
Facility Name
CHU d'AMIENS
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
CH de BEAUVAIS
City
Beauvais
ZIP/Postal Code
60021
Country
France
Facility Name
Service de Chirurgie Digestive - Hôpital Saint-André - CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Service de Chirurgie Générale et Digestive - Hôpital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
Service de Chirurgie Digestive - Hôpital A. Michallon
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
APHP-Kremlin Bicetre
City
Le Kremlin-bicetre
ZIP/Postal Code
94275
Country
France
Facility Name
Département de Chirurgie Oncologique - Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
CHRU Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Lyon
ZIP/Postal Code
69495
Country
France
Facility Name
Département de Chirurgie Oncologique - Institut Paoli Calmette
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Service de Chirurgie Digestive et Viscérale - CHU Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Département de Chirurgie Oncologique - CRLC Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Service de Chirurgie Digestive - CHU de Nantes - Hôtel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Service de Chirurgie Générale et Digestive - Hôpital Saint-Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
APHP- Saint Joseph
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Service de Chirurgie Digestive - Hôpital des Diaconnesses - La Croix Saint-Simon
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
CHU Poitiers
City
Poitiers
Country
France
Facility Name
Service de Chirurgie Viscérale - CHU Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Service de Chirurgie Digestive - CHU Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
CHRU de Strasbourg
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Service de Chirurgie Digestive - Hôpital Purpan - Pavillon Dieulafoy
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Service de Chirurgie Digestive et Générale - Brabois
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France

12. IPD Sharing Statement

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