Early Versus Late Closure of Preventive Ileostomy

April 24, 2023 updated by: Rimantas Bausys, Vilnius University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lithuania
      • Vilnius, Lithuania
        • National Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early closure of preventive ileostomy
A preventive ileostomy is closed 30 days after the primary surgery
Procedure: Deileostomy
Deileostomy
Experimental: Late closure of preventive ileostomy
A preventive ileostomy is closed 90 days after the primary surgery
Procedure: Deileostomy
Deileostomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative morbidity
Time Frame: 30 days after surgery
Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.
30 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalization time after ileostomy closure
Time Frame: 30 days after surgery
Hospitalization time
30 days after surgery
30-days re-admission rate
Time Frame: 30 days after surgery
Re-admission rate during 30 days after re-admission
30 days after surgery
Quality of life of patients after ileostomy closure
Time Frame: at 3, 6, 9 and 12 moths after surgery
Patients quality of life is assessed with EORTC QLQ-C30 questionnaires
at 3, 6, 9 and 12 moths after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vilnius University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2011

Primary Completion (Actual)

November 30, 2018

Study Completion (Actual)

December 30, 2018

Study Registration Dates

First Submitted

December 30, 2018

First Submitted That Met QC Criteria

January 6, 2019

First Posted (Actual)

January 8, 2019

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1 (Other Identifier: Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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