Back to resultsEarly Versus Late Closure of Preventive Ileostomy
Primary Purpose
Ileostomy, Rectal Cancer
Status
Terminated
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Deileostomy
Sponsored by
About this trial
This is an interventional treatment trial for Ileostomy, Rectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients with temporary ileostomy after rectal resection for rectal cancer
- Patients willing to participate in the study
Exclusion Criteria:
- Anastomosis insufficiency detected clinically or radiologically.
- Patients, who are physically and mentally unfit to undergo surgery or to be followed-up
Sites / Locations
- National Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Early closure of preventive ileostomy
Late closure of preventive ileostomy
Arm Description
A preventive ileostomy is closed 30 days after the primary surgery
A preventive ileostomy is closed 90 days after the primary surgery
Outcomes
Primary Outcome Measures
Postoperative morbidity
Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.
Secondary Outcome Measures
Hospitalization time after ileostomy closure
Hospitalization time
30-days re-admission rate
Re-admission rate during 30 days after re-admission
Quality of life of patients after ileostomy closure
Patients quality of life is assessed with EORTC QLQ-C30 questionnaires
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03796702
Brief Title
Early Versus Late Closure of Preventive Ileostomy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
High postoperative morbidity rate
Study Start Date
November 1, 2011 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vilnius University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study is designed and performed as a prospective randomized controlled single-center study. Patients who underwent rectal resection with preventive ileostomy due to rectal cancer will be included. The study investigates the effect of reversing a temporary ileostomy after 30 vs 90 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ileostomy, Rectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early closure of preventive ileostomy
Arm Type
Experimental
Arm Description
A preventive ileostomy is closed 30 days after the primary surgery
Arm Title
Late closure of preventive ileostomy
Arm Type
Experimental
Arm Description
A preventive ileostomy is closed 90 days after the primary surgery
Intervention Type
Procedure
Intervention Name(s)
Deileostomy
Intervention Description
Deileostomy
Primary Outcome Measure Information:
Title
Postoperative morbidity
Description
Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.
Time Frame
30 days after surgery
Secondary Outcome Measure Information:
Title
Hospitalization time after ileostomy closure
Description
Hospitalization time
Time Frame
30 days after surgery
Title
30-days re-admission rate
Description
Re-admission rate during 30 days after re-admission
Time Frame
30 days after surgery
Title
Quality of life of patients after ileostomy closure
Description
Patients quality of life is assessed with EORTC QLQ-C30 questionnaires
Time Frame
at 3, 6, 9 and 12 moths after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with temporary ileostomy after rectal resection for rectal cancer
Patients willing to participate in the study
Exclusion Criteria:
Anastomosis insufficiency detected clinically or radiologically.
Patients, who are physically and mentally unfit to undergo surgery or to be followed-up
Facility Information:
Facility Name
National Cancer Institute
City
Vilnius
Country
Lithuania
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Early Versus Late Closure of Preventive Ileostomy
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