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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
  Purpose

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.


Condition Intervention Phase
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)
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Hartmann vs Resection With Anastomosis and Diverting Stoma for Peritonitis Caused by Perforated Left-sided Colon Diverticulitis: a Multicenter Prospective Randomized Study.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ente Ospedaliero Ospedali Galliera:

Primary Outcome Measures:
  • 30-day mortality and morbidity after emergency surgery [ Time Frame: 30-day ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 30-day mortality and morbidity after elective restoration of intestinal transit [ Time Frame: 30 day ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: January 2000
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01239927

Locations
Italy
Gian Andrea Binda
Genova, Italy, 16100
Sponsors and Collaborators
Ente Ospedaliero Ospedali Galliera
Investigators
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
  More Information

No publications provided

Responsible Party: Gian Andrea Binda MD, Ente Ospedaliero Ospedali Galliera
ClinicalTrials.gov Identifier: NCT01239927     History of Changes
Other Study ID Numbers: PRTHRAPDP
Study First Received: November 12, 2010
Last Updated: November 12, 2010
Health Authority: Italy: National Bioethics Committee

Keywords provided by Ente Ospedaliero Ospedali Galliera:
diverticulitis
hartmann
anastomosis

Additional relevant MeSH terms:
Diverticulitis
Diverticulitis, Colonic
Peritonitis
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Diverticulosis, Colonic
Colonic Diseases
Intestinal Diseases
Peritoneal Diseases

ClinicalTrials.gov processed this record on June 17, 2013