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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)
Sponsored by
Ente Ospedaliero Ospedali Galliera
About
Eligibility
Locations
Outcomes
Full info

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

First Posted
November 12, 2010
Last Updated
November 12, 2010
Sponsor
Ente Ospedaliero Ospedali Galliera
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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
No
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

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Hartmann vs R/A in Peritonitis by Perforated Diverticulitis

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