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Hartmann's Versus Primary Anastomosis in Left-sided Colon Perforation

NCT01233713 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2012-05-28

No results posted yet for this study

Summary

The purpose of this multi-center randomized trial is to identify any differences in the complication rates of patients undergoing Hartmann's (end colostomy) versus Primary Anastomosis (with defunctioning ileostomy) for left-sided colonic performation (including the stoma reversal operation).

Conditions

  • Surgery
  • Diverticulitis
  • Neoplasms
  • Postoperative Complications

Interventions

PROCEDURE

Hartmann's operation

Hartmann's operation is the surgical resection of the rectosigmoid colon with closure of the rectal stump and end colostomy, followed by a stoma reversal operation.

PROCEDURE

Primary anastomosis

Primary anastomosis refers to a colonic resection with primary anastomosis and covering proximal ileostomy, followed by a stoma reversal operation.

Sponsors & Collaborators

  • Kantonsspital Winterthur KSW

    collaborator OTHER

  • University of Lausanne

    collaborator OTHER

  • Kantonsspital Graubünden

    collaborator OTHER

  • University of Zurich

    lead OTHER

Principal Investigators

  • Stefan Breitenstein, MD · University Hospital Zurich, Department of Visceral and Transplant Surgery, Zurich, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • Switzerland

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 NCT01233713 on ClinicalTrials.gov