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Sponsored by: |
University Hospital, Rouen |
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Information provided by: | University Hospital, Rouen |
ClinicalTrials.gov Identifier: | NCT00692393 |
This study compares primary resection with anastomosis and Hartmann's procedure in an adult population with acute perforated colonic diverticulitis (Hinchey Stage III and IV) METHODS: The primary end point was postoperative mortality. Secondary end points included surgical and medical morbidity, operative time, and length of postoperative hospitalization.
Condition | Intervention |
---|---|
Peritonitis |
Procedure: Hartmann intervention Procedure: Protected anastomosis resection |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | Primary vs. Secondary Anastomosis After Sigmoid Colon Resection for Perforated Diverticulitis (Hinchey Stage III and IV): a Prospective Multicentric Randomized Trial |
Estimated Enrollment: | 246 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Surgery : Hartmann intervention
|
Procedure: Hartmann intervention
sigmoid resection, peritoneal and rectal lavage, terminal stoma
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2: Experimental
Surgery : primary resection with anastomosis with protective stoma
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Procedure: Protected anastomosis resection
sigmoid resection , peritoneal and rectal lavage, anastomosis, diverting stoma
|
inclusion criteria: hinchey III and IV diverticulitis
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jean-Jacques TUECH, Professor | 33-23-288-8142 |
France | |
CHU - Rouen | |
Rouen, France, 76031 |
Principal Investigator: | JJ TUECH, PhD | UH Rouen |
Responsible Party: | Direction de la Recherche et de l'Innovation ( Directeur ) |
Study ID Numbers: | 2006/103/HP |
Study First Received: | June 3, 2008 |
Last Updated: | June 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00692393 |
Health Authority: | France: Direction Générale de la Santé |
Diverticulitis Digestive System Diseases Peritonitis Peritoneal Diseases Neoplasm Metastasis |
Pathologic Processes |