Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer

Rectal Cancer Clinical Trial

Official title:

Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01865071
• Other study ID #: S-20110026
• Status: Recruiting
• Phase: N/A
• First received: October 11, 2012
• Last updated: February 4, 2014
• Start date: September 2011
• Est. completion date: October 2015

Study information

• Verified date: February 2014
• Source: Odense University Hospital
• Contact: Mark Ellebæk, MD
• Phone: 004540880511
• Email: markep01[@]gmail.com
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

Early Closure of Temporary Loop Ileostomy After Rectal Resection for cancer

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer

Intervention

Procedure:
• loop ileostomi

Locations

Country	Name	City	State
Denmark	Odense Universityhospital	Odense	Fyn

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Death occurring during the first 90 postoperative days	Death occurring during the first 90 days	No