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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00692393
First Posted: June 6, 2008
Last Update Posted: June 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Rouen
  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: None (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:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Death rate comparison between two chirurgical strategies [ Time Frame: 18 months ]

Enrollment: 102
Study Start Date: June 2008
Study Completion Date: November 2013
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00692393


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: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00692393     History of Changes
Other Study ID Numbers: 2006/103/HP
First Submitted: June 3, 2008
First Posted: June 6, 2008
Last Update Posted: June 19, 2014
Last Verified: June 2014

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