Early Reversal of Defunctioning Stoma Trial (ELSOR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Rectal Cancer Trial on Defunctioning Stoma Study Group.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rectal Cancer Trial on Defunctioning Stoma Study Group
ClinicalTrials.gov Identifier:
NCT00640913
First received: March 10, 2008
Last updated: March 19, 2008
Last verified: March 2008
  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: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Early Reversal of Defunctioning Stoma Trial

Resource links provided by NLM:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Peter Matthiessen, MD, PhD, Department of Surgery, Örebro University Hospital, 701 85 Örebro
ClinicalTrials.gov Identifier: NCT00640913     History of Changes
Other Study ID Numbers: Ö 109-07
Study First Received: March 10, 2008
Last Updated: March 19, 2008
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

ClinicalTrials.gov processed this record on September 18, 2014