NCT00640913

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 10, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 21, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

March 21, 2008

Status Verified

March 1, 2008

Enrollment Period

1.2 years

First QC Date

March 10, 2008

Last Update Submit

March 19, 2008

Conditions

Rectal Cancer

Keywords

Defunctioning stomaLow anterior resectionTME surgeryEarly stoma reversal

Outcome Measures

Primary Outcomes (1)

  • Reversal of defunctioning loop stoma on postoperative day 14 following low anterior resection of the rectum for cancer with or without preoperative adjuvant treatment

    Preoperatively, postoperative day 7, postoperative day 30 and at 6 months postoperatively

Secondary Outcomes (1)

  • Postoperative 30 day morbidity. Postoperative ano-rectal function at 1 and 6 months.

    Postoperatively at 1 and 6 months.

Study Arms (1)

I

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

Procedure: Reversal of defunctioning stoma

Interventions

Reversal of defunctioning stomaPROCEDURE

Reversal of defunctioning stoma

I

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Twenty patients operated on with low anterior resection of the rectum for cancer and a defunctioning loop stoma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Örebro University Hospital

Örebro, 701 85, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Analysis of serum C-Reactive Protein (CRP) and Procalcitonin (PCT).

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Peter Matthiessen, MD, PhD

    Department of Surgery, Örebro University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Matthiessen, MD, PhD

CONTACT

0046 19 602 20 76peter.matthiessen@orebroll.se

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 10, 2008

First Posted

March 21, 2008

Study Start

February 1, 2008

Primary Completion

April 1, 2009

Study Completion

November 1, 2009

Last Updated

March 21, 2008

Record last verified: 2008-03

Locations

SE(1)