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

Tracking Information

First Received Date ^ICMJE

November 12, 2010

Last Updated Date

November 12, 2010

Start Date ^ICMJE

January 2000

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Hartmann vs R/A in Peritonitis by Perforated Diverticulitis

Official Title ^ICMJE

Hartmann vs Resection With Anastomosis and Diverting Stoma for Peritonitis Caused by Perforated Left-sided Colon Diverticulitis: a Multicenter Prospective Randomized Study.

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment

Condition ^ICMJE

Peritonitis Caused by Perforated Left-sided Colon Diverticulitis

Intervention ^ICMJE

Procedure: Primary sigmoid resection with end colostomy (Hartmann)
Procedure: Primary sigmoid resection and immediate anastomosis with diverting stoma (PRA)

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

100

Completion Date

July 2010

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Intraoperative demonstrated peritonitis caused by perforated left-sided colon diverticulitis

Exclusion Criteria:

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT01239927

Other Study ID Numbers ^ICMJE

PRTHRAPDP

Has Data Monitoring Committee

Yes

Responsible Party

Gian Andrea Binda MD, Ente Ospedaliero Ospedali Galliera

Study Sponsor ^ICMJE

Ente Ospedaliero Ospedali Galliera

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Ente Ospedaliero Ospedali Galliera

Verification Date

July 2010

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

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