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Early Reversal of Defunctioning Stoma Trial

NCT ID: NCT00640913

Last Updated: 2008-03-21

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

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-11-30

Brief Summary

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In this trial will be investigated if a defunctioning loop stoma used in low anterior resection of the rectum for cancer can be reversed after 14 days instead of 3-12 months which is present clinical practise.

Detailed Description

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Patients undergoing low anterior resection of the the rectum for adenocarcinom (total mesorectal excision; TME) with a defunctioning loop stoma are assessed preoperatively and for 6 days postoperatively according to a trial protocol including daily clinical, physiological, and serological variables, and a rectal contrast study on day 6. If inclusion criteria are fulfilled, a decision is taken on day 7 to schedule reversal of the defunctioning loop stoma on postoperative day 14. This trial is considered a hypothesis generating pilot study of feasibility type and is no power calculation. The present trial will include 20 consecutive patients who accept participation.

Conditions

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Rectal Cancer

Keywords

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Defunctioning stoma Low anterior resection TME surgery Early stoma reversal

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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I

Twenty consecutive patients operated on with low anterior resection of the rectum for cancer with a defunctioning stoma who accept participation.

Reversal of defunctioning stoma

Intervention Type PROCEDURE

Reversal of defunctioning stoma

Interventions

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Reversal of defunctioning stoma

Reversal of defunctioning stoma

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria:

* Written consent and fulfilled inclusion criteria preoperatively and during postoperative day 1-6.

Exclusion Criteria:

* Written consent and/or inclusion criteria not fulfilled preoperatively and during postoperative day 1-6.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rectal Cancer Trial on Defunctioning Stoma Study Group

OTHER

Sponsor Role lead

Responsible Party

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Department of Surgery, Örebro University Hospital, 701 85 Örebro

Principal Investigators

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Peter Matthiessen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, Örebro University Hospital

Locations

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Department of Surgery, Örebro University Hospital

Örebro, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Peter Matthiessen, MD, PhD

Role: CONTACT

Phone: 0046 19 602 20 76

Email: [email protected]

Facility Contacts

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Rickard Lindgren, MD

Role: primary

Other Identifiers

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Ö 109-07

Identifier Type: -

Identifier Source: org_study_id