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Comparative Study of Circular Stapling Instruments

NCT00399009 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 880

Last updated 2008-06-09

No results posted yet for this study

Summary

After removing the rectum at surgery, bowel continuity can sometimes be restored by an anastomosis between the anus and the bowel. This anastomosis is most commonly created by the use of surgical circular stapling instruments. In a retrospective pilot study the risk of developing an acute leak in the anastomosis was increased with one of the most commonly used instruments in Sweden as compared to the other brand in use. In the current study the patient is randomized to either one of the instruments after a resection of the rectum for rectal cancer.

Conditions

Interventions

DEVICE

AutoSuture Premium Plus CEEA/Ethicon Proximate ILS

Sponsors & Collaborators

  • Uppsala University Hospital

    lead OTHER

Principal Investigators

  • Joakim Folkesson, M.D Ph.D. · Uppsala University

  • Lars Påhlman, Professor M.D. Ph.D. · Uppsala University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2007-11-30
Completion
2007-11-30

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

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 NCT00399009 on ClinicalTrials.gov