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Primary vs. Secondary Anastomosis for Hinchey Stage III-IV Diverticulitis a Prospective Randomized Trial (DIVERTI)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by University Hospital, Rouen.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00692393
First received: June 3, 2008
Last updated: December 24, 2012
Last verified: October 2009
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Primary vs. Secondary Anastomosis After Sigmoid Colon Resection for Perforated Diverticulitis (Hinchey Stage III and IV): a Prospective Multicentric Randomized Trial

Resource links provided by NLM:

U.S. FDA Resources

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
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Surgery : Hartmann intervention
 Procedure: Hartmann intervention
sigmoid resection, peritoneal and rectal lavage, terminal stoma
Experimental: 2
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 Recruiting
Rouen, France, 76031
Contact: Jean-jacques TUECH     33-23-288-8142        
Principal Investigator: Jean-Jacques TUECH            
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: JJ TUECH, PhD UH Rouen
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00692393     History of Changes
Other Study ID Numbers: 2006/103/HP
Study First Received: June 3, 2008
Last Updated: December 24, 2012
Health Authority: France: Direction Générale de la Santé

Additional relevant MeSH terms:
Diverticulitis
Peritonitis
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Peritoneal Diseases

ClinicalTrials.gov processed this record on June 18, 2013