Rectal Cancer Surgery Without Mechanical Bowel Preparation
PREPACOL
ClinicalTrial in Rectal Cancer Surgery Without Mechanical Bowel Preparation
3 other identifiers
interventional
186
1 country
11
Brief Summary
The aim of this controlled multicentric study is to assess rectal cancer surgery with sphincter preservation without pre operative mechanical bowel preparation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2007
Typical duration for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 6, 2007
CompletedFirst Posted
Study publicly available on registry
November 7, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedJune 30, 2010
June 1, 2010
1.4 years
November 6, 2007
June 29, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall morbidity including infectious and non infectious complications
peri operative
Secondary Outcomes (2)
- peri operative mortality - non infectious morbidity - anastomotic leakage - hospital stay - per operative evaluation of bowel preparation - clinical evaluation of bowel preparation
30 days, 6 months
Evaluate the postoperative complications classified according to the DINDO classification.
during the study
Study Arms (2)
1
ACTIVE COMPARATORBowel preparation
2
EXPERIMENTALwithout bowel preparation
Interventions
Eligibility Criteria
You may qualify if:
- Age \> 18 years
- patient with rectal cancer without any metastasesRectal excision with sphincter preservation with colorectal or coloanal anastomosis (with or without temporary ileostomy)
You may not qualify if:
- Stage IV disease
- Comorbidity with post operative infectious risk corticoids,immunodeficiency, Crohn's disease, ulcerative colitis ...)
- Abdominoperineal resection
- Emergency surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
CHU
Angers, 49000, France
Hopital Saint André
Bordeaux, 33075, France
Hopital Ambroise Paré
Boulognes Billancourt, 92100, France
CHU
Clermont-Ferrand, 63000, France
Hôpital Beaujon
Clichy, 92110, France
Hopital Nord
Marseille, 13000, France
Institut Paoli Calmette
Marseille, 13273, France
CRLC Val d'Aurelle
Montpellier, 34298, France
Hopital Cochin
Paris, 75014, France
CHU Purpan
Toulouse, 31059, France
CHRU Trousseau
Tours, 37044, France
Related Publications (1)
Bretagnol F, Panis Y, Rullier E, Rouanet P, Berdah S, Dousset B, Portier G, Benoist S, Chipponi J, Vicaut E; French Research Group of Rectal Cancer Surgery (GRECCAR). Rectal cancer surgery with or without bowel preparation: The French GRECCAR III multicenter single-blinded randomized trial. Ann Surg. 2010 Nov;252(5):863-8. doi: 10.1097/SLA.0b013e3181fd8ea9.
PMID: 21037443DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
PANIS Yves, Pr
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 6, 2007
First Posted
November 7, 2007
Study Start
September 1, 2007
Primary Completion
February 1, 2009
Study Completion
August 1, 2009
Last Updated
June 30, 2010
Record last verified: 2010-06