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Hartmann vs R/A in Peritonitis by Perforated Diverticulitis

This study has been completed.
Sponsor:
Information provided by:
Ente Ospedaliero Ospedali Galliera
ClinicalTrials.gov Identifier:
NCT01239927
First received: November 12, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted

November 12, 2010
November 12, 2010
January 2000
July 2010   (final data collection date for primary outcome measure)
30-day mortality and morbidity after emergency surgery [ Time Frame: 30-day ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
30-day mortality and morbidity after elective restoration of intestinal transit [ Time Frame: 30 day ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Hartmann vs R/A in Peritonitis by Perforated Diverticulitis
Hartmann vs Resection With Anastomosis and Diverting Stoma for Peritonitis Caused by Perforated Left-sided Colon Diverticulitis: a Multicenter Prospective Randomized Study.

This prospective randomized trial is to prove the equivalence of primary sigmoid resection with end colostomy(Hartmann)(GROUP A) and primary sigmoid resection and immediate anastomosis with diverting stoma (GROUP B)with regard to morbidity and mortality in patients with peritonitis caused by perforated left-sided colon diverticulitis.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Peritonitis Caused by Perforated Left-sided Colon Diverticulitis
  • Procedure: Primary sigmoid resection with end colostomy (Hartmann)
  • Procedure: Primary sigmoid resection and immediate anastomosis with diverting stoma (PRA)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
July 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Intraoperative demonstrated peritonitis caused by perforated left-sided colon diverticulitis

Exclusion Criteria:

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01239927
PRTHRAPDP
Yes
Gian Andrea Binda MD, Ente Ospedaliero Ospedali Galliera
Ente Ospedaliero Ospedali Galliera
Not Provided
Study Chair: Roberto Bergamaschi, MD Division of Colon & Rectal Surgery State University of New York Stony Brook, New York
Study Director: Gian Andrea Binda EO Ospedali Galliera, Genova, Italy
Principal Investigator: Alberto Serventi EO Ospedali Galliera, Genova, Italy
Ente Ospedaliero Ospedali Galliera
July 2010

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