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Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer

Primary Purpose

Rectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
loop ileostomi
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring ileostomy, rectal resection, proctectomy, stoma closure, rectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Sites / Locations

  • Odense UniversityhospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

loop ileostomi

Arm Description

Compare early vs. late closer of the protecting ileostoma in patients requiring rectal resection for rectal cancer

Outcomes

Primary Outcome Measures

Mortality
Death occurring during the first 90 postoperative days

Secondary Outcome Measures

Full Information

First Posted
October 11, 2012
Last Updated
February 4, 2014
Sponsor
Odense University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01865071
Brief Title
Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer
Official Title
Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
October 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
ileostomy, rectal resection, proctectomy, stoma closure, rectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
loop ileostomi
Arm Type
Experimental
Arm Description
Compare early vs. late closer of the protecting ileostoma in patients requiring rectal resection for rectal cancer
Intervention Type
Procedure
Intervention Name(s)
loop ileostomi
Primary Outcome Measure Information:
Title
Mortality
Description
Death occurring during the first 90 postoperative days
Time Frame
Death occurring during the first 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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:
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Ellebæk, MD
Phone
004540880511
Email
markep01@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Ellebæk, MD
Organizational Affiliation
Odense Universityhospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odense Universityhospital
City
Odense
State/Province
Fyn
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Ellebæk, MD
Phone
004540880511

12. IPD Sharing Statement

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Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer

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