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

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. Identifier: NCT00692393
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : June 19, 2014
Information provided by (Responsible Party):
University Hospital, Rouen

June 3, 2008
June 6, 2008
June 19, 2014
June 2008
December 2012   (Final data collection date for primary outcome measure)
Death rate comparison between two chirurgical strategies [ Time Frame: 18 months ]
Same as current
Complete list of historical versions of study NCT00692393 on Archive Site
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Primary vs. Secondary Anastomosis for Hinchey Stage III-IV Diverticulitis a Prospective Randomized Trial
Primary vs. Secondary Anastomosis After Sigmoid Colon Resection for Perforated Diverticulitis (Hinchey Stage III and IV): a Prospective Multicentric Randomized Trial
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.
inclusion criteria: hinchey III and IV diverticulitis
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Procedure: Hartmann intervention
    sigmoid resection, peritoneal and rectal lavage, terminal stoma
  • Procedure: Protected anastomosis resection
    sigmoid resection , peritoneal and rectal lavage, anastomosis, diverting stoma
  • Active Comparator: 1
    Surgery : Hartmann intervention
    Intervention: Procedure: Hartmann intervention
  • Experimental: 2
    Surgery : primary resection with anastomosis with protective stoma
    Intervention: Procedure: Protected anastomosis resection
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2013
December 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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University Hospital, Rouen
University Hospital, Rouen
Not Provided
Principal Investigator: JJ TUECH, PhD UH Rouen
University Hospital, Rouen
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP