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Hartmann vs R/A in Peritonitis by Perforated Diverticulitis

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ClinicalTrials.gov Identifier: NCT01239927
Recruitment Status : Completed
First Posted : November 15, 2010
Last Update Posted : November 15, 2010
Sponsor:
Information provided by:
Ente Ospedaliero Ospedali Galliera

Brief Summary:
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 or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 100 participants
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.
Study Start Date : January 2000
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

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U.S. FDA Resources




Primary Outcome Measures :
  1. 30-day mortality and morbidity after emergency surgery [ Time Frame: 30-day ]

Secondary Outcome Measures :
  1. 30-day mortality and morbidity after elective restoration of intestinal transit [ Time Frame: 30 day ]


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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:


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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

Responsible Party: Gian Andrea Binda MD, Ente Ospedaliero Ospedali Galliera
ClinicalTrials.gov Identifier: NCT01239927     History of Changes
Other Study ID Numbers: PRTHRAPDP
First Posted: November 15, 2010    Key Record Dates
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