Hartmann vs R/A in Peritonitis by Perforated Diverticulitis

November 12, 2010 updated by: Ente Ospedaliero Ospedali Galliera

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Genova, Italy, 16100
        • Gian Andrea Binda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
30-day mortality and morbidity after emergency surgery
Time Frame: 30-day
30-day

Secondary Outcome Measures

Outcome Measure
Time Frame
30-day mortality and morbidity after elective restoration of intestinal transit
Time Frame: 30 day
30 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

November 12, 2010

First Submitted That Met QC Criteria

November 12, 2010

First Posted (Estimate)

November 15, 2010

Study Record Updates

Last Update Posted (Estimate)

November 15, 2010

Last Update Submitted That Met QC Criteria

November 12, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRTHRAPDP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Peritonitis Caused by Perforated Left-sided Colon Diverticulitis

  • King Faisal Specialist Hospital & Research Center
    Not yet recruiting
    Saudi Emergency Laparotomy Audit (SELA)
    Gastrointestinal Diseases | Sepsis | Mortality | Intestinal Obstruction | Peritonitis Infectious | Laparotomy | Emergency Treatment | Intestinal Ischemia | Intestinal Perforation | Surgical Procedures, Operative | Peritonitis Caused by Perforated Left-sided Colon Diverticulitis | Intestinal Obstruction and Ileus and other conditions
    Saudi Arabia
  • Medtronic - MITG
    Recruiting
    Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections (SECURE)
    Digestive System Diseases | Gastrointestinal Diseases | Postoperative Complications | Colonic Diseases | Intestinal Diseases | Rectal Diseases | Anastomotic Leak | Anastomotic Complication | Left-sided Colon Resection | Colorectal Anastomosis | Anastomotic Leaks
    United States

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