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Hartmann vs R/A in Peritonitis by Perforated Diverticulitis

NCT ID: NCT01239927

Last Updated: 2010-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-31

Study Completion Date

2010-07-31

Brief Summary

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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

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Conditions

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Peritonitis Caused by Perforated Left-sided Colon Diverticulitis

Keywords

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diverticulitis hartmann anastomosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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Primary sigmoid resection with end colostomy (Hartmann)

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Intraoperative demonstrated peritonitis caused by perforated left-sided colon diverticulitis
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ente Ospedaliero Ospedali Galliera

OTHER

Sponsor Role lead

Responsible Party

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Ente Ospedaliero Ospedali Galliera

Principal Investigators

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Roberto Bergamaschi, MD

Role: STUDY_CHAIR

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

Gian Andrea Binda

Role: STUDY_DIRECTOR

EO Ospedali Galliera, Genova, Italy

Alberto Serventi

Role: PRINCIPAL_INVESTIGATOR

EO Ospedali Galliera, Genova, Italy

Locations

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Gian Andrea Binda

Genova, Genova, Italy

Site Status

Countries

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Italy

Other Identifiers

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PRTHRAPDP

Identifier Type: -

Identifier Source: org_study_id