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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

June 3, 2008
December 24, 2012
June 2008
December 2012   (final data collection date for primary outcome measure)
Death rate comparison between two chirurgical strategies [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00692393 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Peritonitis
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
246
December 2012
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
Both
18 Years and older
No
Contact: Jean-Jacques TUECH, Professor 33-23-288-8142
France
 
NCT00692393
2006/103/HP
No
University Hospital, Rouen
University Hospital, Rouen
Not Provided
Principal Investigator: JJ TUECH, PhD UH Rouen
University Hospital, Rouen
October 2009

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