Early Reversal of Defunctioning Stoma Trial - Full Text View

Sponsored by:	Rectal Cancer Trial on Defunctioning Stoma Study Group
Information provided by:	Rectal Cancer Trial on Defunctioning Stoma Study Group
ClinicalTrials.gov Identifier:	NCT00640913

Purpose

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.

Condition	Intervention
Rectal Cancer	Procedure: Reversal of defunctioning stoma

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Early Reversal of Defunctioning Stoma Trial

Resource links provided by NLM:

MedlinePlus related topics: Cancer Surgery

U.S. FDA Resources

Further study details as provided by Rectal Cancer Trial on Defunctioning Stoma Study Group:

Primary Outcome Measures:

Reversal of defunctioning loop stoma on postoperative day 14 following low anterior resection of the rectum for cancer with or without preoperative adjuvant treatment [ Time Frame: Preoperatively, postoperative day 7, postoperative day 30 and at 6 months postoperatively ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Postoperative 30 day morbidity. Postoperative ano-rectal function at 1 and 6 months. [ Time Frame: Postoperatively at 1 and 6 months. ] [ Designated as safety issue: Yes ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

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

Estimated Enrollment:	20
Study Start Date:	February 2008
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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 Reversal of defunctioning stoma

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640913

Contacts

Contact: Peter Matthiessen, MD, PhD

0046 19 602 20 76

peter.matthiessen@orebroll.se

Locations

Sweden
Department of Surgery, Örebro University Hospital	Recruiting
Örebro, Sweden, 701 85
Contact: Rickard Lindgren, MD 0046 19 602 10 00 rickard.lindgren@orebroll.se

Sponsors and Collaborators

Rectal Cancer Trial on Defunctioning Stoma Study Group

Investigators

Principal Investigator:

Peter Matthiessen, MD, PhD

Department of Surgery, Örebro University Hospital

More Information

No publications provided

Responsible Party:	Department of Surgery, Örebro University Hospital, 701 85 Örebro ( Peter Matthiessen, MD, PhD )
Study ID Numbers:	Ö 109-07
Study First Received:	March 10, 2008
Last Updated:	March 19, 2008
ClinicalTrials.gov Identifier:	NCT00640913 History of Changes
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by Rectal Cancer Trial on Defunctioning Stoma Study Group:

Defunctioning stoma
Low anterior resection
TME surgery
Early stoma reversal

Study placed in the following topic categories:

Rectal Cancer
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Rectal Neoplasms
Rectal Neoplasm

Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Rectal Neoplasms

Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on September 10, 2009