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Hartmann vs R/A in Peritonitis by Perforated Diverticulitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01239927
First Posted: November 15, 2010
Last Update Posted: November 15, 2010
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:
Ente Ospedaliero Ospedali Galliera
  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
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:


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 ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  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): 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

Responsible Party: Gian Andrea Binda MD, Ente Ospedaliero Ospedali Galliera
ClinicalTrials.gov Identifier: NCT01239927     History of Changes
Other Study ID Numbers: PRTHRAPDP
First Submitted: November 12, 2010
First Posted: November 15, 2010
Last Update Posted: November 15, 2010
Last Verified: July 2010

Keywords provided by Ente Ospedaliero Ospedali Galliera:
diverticulitis
hartmann
anastomosis

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