Primary vs. Secondary Anastomosis for Hinchey Stage III-IV Diverticulitis a Prospective Randomized Trial - Full Text View

Sponsored by:	University Hospital, Rouen
Information provided by:	University Hospital, Rouen
ClinicalTrials.gov Identifier:	NCT00692393

Purpose

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

MedlinePlus related topics: Diverticulosis and Diverticulitis

U.S. FDA Resources

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

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:

Death rate comparison between two chirurgical strategies [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

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
2: Experimental Surgery : primary resection with anastomosis with protective stoma	Procedure: Protected anastomosis resection sigmoid resection , peritoneal and rectal lavage, anastomosis, diverting stoma

Detailed Description:

inclusion criteria: hinchey III and IV diverticulitis

Eligibility

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

Criteria

Inclusion Criteria:

Patient with peritonitis du to sigmoid diverticulum complication
Surgeon - anesthetist confirming the 2 surgeries can be performed

Exclusion Criteria:

Physical state which can not permit patient to participate
contraindication to surgery
non-diverticulum peritonitis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00692393

Contacts

Contact: Jean-Jacques TUECH, Professor

33-23-288-8142

Locations

France
CHU - Rouen
Rouen, France, 76031

Sponsors and Collaborators

University Hospital, Rouen

Investigators

Principal Investigator:

JJ TUECH, PhD

UH Rouen

More Information

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

Study placed in the following topic categories:

Diverticulitis
Digestive System Diseases
Peritonitis
Peritoneal Diseases
Neoplasm Metastasis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009