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Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer

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ClinicalTrials.gov Identifier: NCT01865071
Recruitment Status : Unknown
Verified February 2014 by Mark Ellebaek Pedersen, Odense University Hospital.
Recruitment status was:  Recruiting
First Posted : May 30, 2013
Last Update Posted : February 5, 2014
Sponsor:
Information provided by (Responsible Party):
Mark Ellebaek Pedersen, Odense University Hospital

Brief Summary:
Early Closure of Temporary Loop Ileostomy After Rectal Resection for cancer

Condition or disease Intervention/treatment Phase
Rectal Cancer Procedure: loop ileostomi Not Applicable

Detailed Description:

The aim of this prospective randomized study is to compare early vs. late closer of the protecting ileostoma in patients requiring rectal resection for rectal cancer.

Early closer is defined as postoperative days 8-12 and delayed as later then 3 months.

Inclusion criteria is aged 18 years or older with rectal carcinoma, requiring rectal resection with a protecting ileostoma.

A CT-water-soluble contrast enema examination per rectum is performed at day 7, to evaluate the anastomosis in all patients. The patients will be randomized after the "intention-to-treat" principle, before the primary operation.

If there is no radiologic signs of contrast leakage ore other contraindications for early closer as septic episodes ore missing bowl movements the early closure will be preformed.

Primary end point is the rate of either postoperative death or postoperative complications occurring at 90 days after the rectal resection.

Major and minor postoperative complications (anastomotic leakage, post operative death, anastomotic fistula, postoperative peritonitis, pneumonia etc) and stoma related complications (prolapsus or peristomial eventration, erosive peristomal dermatitis, dehydration with hydroelectrolytic disorders, occlusive syndrome) would be registered.

LARS score and EORTC QLQ-30 will be sent preoperatively and after 3, 6, 12 and 24 months postoperatively.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer
Study Start Date : September 2011
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : October 2015

Arm Intervention/treatment
Experimental: loop ileostomi
Compare early vs. late closer of the protecting ileostoma in patients requiring rectal resection for rectal cancer
Procedure: loop ileostomi



Primary Outcome Measures :
  1. Mortality [ Time Frame: Death occurring during the first 90 days ]
    Death occurring during the first 90 postoperative days



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients aged 18 years or older.
  • All patients with rectal carcinoma, requiring elective rectal resection with primary anastomosis and an protecting ileostoma
  • Written informed consent was obtained from all patients

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865071


Contacts
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Contact: Mark Ellebæk, MD 004540880511 markep01@gmail.com

Locations
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Denmark
Odense Universityhospital Recruiting
Odense, Fyn, Denmark, 5000
Contact: Mark Ellebæk, MD    004540880511      
Sponsors and Collaborators
Odense University Hospital
Investigators
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Principal Investigator: Mark Ellebæk, MD Odense Universityhospital

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Responsible Party: Mark Ellebaek Pedersen, Doctor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01865071     History of Changes
Other Study ID Numbers: S-20110026
First Posted: May 30, 2013    Key Record Dates
Last Update Posted: February 5, 2014
Last Verified: February 2014
Keywords provided by Mark Ellebaek Pedersen, Odense University Hospital:
ileostomy
rectal resection
proctectomy
stoma closure
rectal cancer
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases