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Hartmann vs R/A in Peritonitis by Perforated Diverticulitis

NCT01239927 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2010-11-15

No results posted yet for this study

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.

Conditions

  • Peritonitis Caused by Perforated Left-sided Colon Diverticulitis

Interventions

PROCEDURE

Primary sigmoid resection with end colostomy (Hartmann)

PROCEDURE

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

Sponsors & Collaborators

  • Ente Ospedaliero Ospedali Galliera

    lead OTHER

Principal Investigators

  • Roberto Bergamaschi, MD · Division of Colon & Rectal Surgery State University of New York Stony Brook, New York

  • Gian Andrea Binda · EO Ospedali Galliera, Genova, Italy

  • Alberto Serventi · EO Ospedali Galliera, Genova, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-01-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01239927 on ClinicalTrials.gov