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Hartmann vs R/A in Peritonitis by Perforated Diverticulitis

Primary Purpose

Peritonitis Caused by Perforated Left-sided Colon Diverticulitis

Status

Completed

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

Primary sigmoid resection with end colostomy (Hartmann)

Primary sigmoid resection and immediate anastomosis with diverting stoma (PRA)

About this trial

This is an interventional treatment trial for Peritonitis Caused by Perforated Left-sided Colon Diverticulitis focused on measuring diverticulitis, hartmann, anastomosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Intraoperative demonstrated peritonitis caused by perforated left-sided colon diverticulitis

Exclusion Criteria:

Sites / Locations

Gian Andrea Binda

Outcomes

Primary Outcome Measures

30-day mortality and morbidity after emergency surgery

Secondary Outcome Measures

30-day mortality and morbidity after elective restoration of intestinal transit

Full Information

NCT ID

NCT01239927

First Posted

November 12, 2010

Last Updated

November 12, 2010

Sponsor

Ente Ospedaliero Ospedali Galliera

1. Study Identification

Unique Protocol Identification Number

NCT01239927

Brief Title

Hartmann vs R/A in Peritonitis by Perforated Diverticulitis

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 Type

Interventional

2. Study Status

Record Verification Date

July 2010

Overall Recruitment Status

Completed

Study Start Date

January 2000 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Ente Ospedaliero Ospedali Galliera

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peritonitis Caused by Perforated Left-sided Colon Diverticulitis

Keywords

diverticulitis, hartmann, anastomosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Primary sigmoid resection with end colostomy (Hartmann)

Intervention Type

Procedure

Intervention Name(s)

Primary sigmoid resection and immediate anastomosis with diverting stoma (PRA)

Primary Outcome Measure Information:

Title

30-day mortality and morbidity after emergency surgery

Time Frame

30-day

Secondary Outcome Measure Information:

Title

30-day mortality and morbidity after elective restoration of intestinal transit

Time Frame

30 day

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Intraoperative demonstrated peritonitis caused by perforated left-sided colon diverticulitis Exclusion Criteria:

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roberto Bergamaschi, MD

Organizational Affiliation

Division of Colon & Rectal Surgery State University of New York Stony Brook, New York

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Gian Andrea Binda

Organizational Affiliation

EO Ospedali Galliera, Genova, Italy

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Alberto Serventi

Organizational Affiliation

EO Ospedali Galliera, Genova, Italy

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gian Andrea Binda

City

Genova

ZIP/Postal Code

16100

Country

Italy

12. IPD Sharing Statement

Learn more about this trial

Hartmann vs R/A in Peritonitis by Perforated Diverticulitis

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