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Comparative Study of Circular Stapling Instruments

NCT ID: NCT00399009

Last Updated: 2008-06-09

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

TERMINATED

Clinical Phase

NA

Total Enrollment

880 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2007-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Anastomotic Leak Rectal Cancer

Keywords

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Circular stapling devices anastomotic leak anastomotic dehiscence rectal cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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AutoSuture Premium Plus CEEA/Ethicon Proximate ILS

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age over 18
* Anterior resection for Rectal Cancer
* Informed consent

Exclusion Criteria

* Can not give informed consent
* Patient can not be followed
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Joakim Folkesson, M.D Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Lars Påhlman, Professor M.D. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

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Uppsala University Hospital

Uppsala, , Sweden

Site Status

Countries

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Sweden

References

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Folkesson J, Brown SS, Gunnarsson U, Pahlman L. Randomised multicentre trial of circular stapling devices. Int J Colorectal Dis. 2012 Feb;27(2):227-32. doi: 10.1007/s00384-011-1307-4. Epub 2011 Sep 10.

Reference Type DERIVED
PMID: 21909698 (View on PubMed)

Other Identifiers

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Ups03-130

Identifier Type: -

Identifier Source: org_study_id