Early Closure of Temporary Ileostomy (EASY)

January 16, 2016 updated by: Anne Kjærgaard Danielsen, Herlev Hospital

Early Closure of Temporary Ileostomy- a Randomized Clinical Trial

The study is being conducted as a prospective randomized controlled multicenter study of patients with a temporary ileostomy due to rectal cancer. The study will be conducted in hospitals in Denmark and Sweden under the framework of the Scandinavian Surgical Outcomes Group (www.ssorg.net).

The study investigates the effect of reversing a temporary ileostomy after 8-13 days instead of later reversal more than 12 weeks after surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After creation of the temporary ileostomy patients are included and are randomized to two groups. Patients in the intervention group will have the stoma closed 8-13 days after stoma creation and will be compared to patients in the control group where the stoma is closed after a minimum of 12 weeks (standard treatment in Denmark and Sweden).

Before randomization the eligible patients undergo a CT of the rectum to visualise the anastomosis and possible leakage. Furthermore, the local investigators may choose to supplement the CT with a rectoscopy.

The research group includes 89 patients over an expected period of 4 years. Both groups are examined for postoperative complications as well as stoma-related complications at discharge and 3, 6 and 12 months after stoma creation.

The research group also examines the impact on patients´ health-related quality of life at 3, 6 and 12 months after stoma creation.

Finally the socio-economic effect in both groups will be analyzed and compared 6 and 12 months after stoma creation.

An interim analysis is planned for safety as well as recalculation of statistical power.

Study Type

Interventional

Enrollment (Actual)

89

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

  • Denmark
      • Herlev, Denmark, 2730
        • Herlev Hospital, University of Copenhagen

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with a temporary ileostomy after low anterior resection because of rectal cancer
  • Patients, who are physically and mentally fit to undergo surgery within 8-13 days

Exclusion Criteria:

  • Patients whose stoma is not reversible
  • Patients with diabetes
  • Patients being treated with Steroids
  • Patients with communicative problems
  • Patients with expected compliance issues

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early reversal group
Early reversal of temporary ileostomy
Procedure: Early reversal of temporary ileostomy
Temporary ileostomy is reversed 8-13 days after the primary surgery
Other Names:
  • stoma reversal 8-13 days post surgery
Active Comparator: Control group
Standard reversal of temporary ileostomy
Procedure: Standard reversal of temporary ileostomy
Patients in the control group will have the ileostomy reversed according to standard treatment, which is 12-26 weeks after primary operation
Other Names:
  • stoma reversal 12-26 weeks after stoma creation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postsurgical morbidity
Time Frame: 3 months after inclusion
Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.
3 months after inclusion
Postsurgical morbidity
Time Frame: 6 months after inclusion
Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.
6 months after inclusion
Postsurgical morbidity.
Time Frame: 12 months after inclusion-
Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.
12 months after inclusion-

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: Quality of life is assessed at 3 months after inclusion
Patients quality of life is assessed with three questionnaires that supplement each other: Short Form 36 (SF-36), Ostomy Adjustment Scale (OAS) and European Organization for the Treatment of Cancer CR30+CR29 (EORTC QLQ-CR30+CR29)
Quality of life is assessed at 3 months after inclusion
Quality of life
Time Frame: Quality of life is assessed at 6 months after inclusion
Patients quality of life is assessed with three questionnaires that supplement each other: Short Form 36 (SF-36), Ostomy Adjustment Scale (OAS) and European Organization for the Treatment of Cancer CR30+CR29 (EORTC QLQ-CR30+CR29)
Quality of life is assessed at 6 months after inclusion
Quality of life
Time Frame: Quality of life is assessed at 12 months after inclusion
Patients quality of life is assessed with three questionnaires that supplement each other: Short Form 36 (SF-36), Ostomy Adjustment Scale (OAS) and European Organization for the Treatment of Cancer CR30+CR29 (EORTC QLQ-CR30+CR29)
Quality of life is assessed at 12 months after inclusion
Socio-economic effect of early reversal of temporary ileostomy
Time Frame: The investigators assess and analyze the economic effect 6 months after inclusion
The investigators register all admissions to hospital and out-patient clinics up to 12 months after the operation. Furthermore, the investigators apply patients´self-reported data on visits to general practitioner, primary care nurses and other health care workers in primary care.
The investigators assess and analyze the economic effect 6 months after inclusion
Socio-economic effect of early reversal of temporary ileostomy
Time Frame: The investigators assess and analyze the economic effect 12 months after inclusion
The investigators register all admissions to hospital and out-patient clinics up to 12 months after the operation. Furthermore, the investigators apply patients´self-reported data on visits to general practitioner, primary care nurses and other health care workers in primary care.
The investigators assess and analyze the economic effect 12 months after inclusion

Collaborators and Investigators

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

Sponsor

Herlev Hospital

Investigators

  • Principal Investigator: Jacob Rosenberg, Professor, Herlev Hospital, University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2011

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

January 28, 2011

First Submitted That Met QC Criteria

January 31, 2011

First Posted (Estimate)

February 1, 2011

Study Record Updates

Last Update Posted (Estimate)

January 20, 2016

Last Update Submitted That Met QC Criteria

January 16, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AKD03

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.

Clinical Trials on Rectal Cancer

Clinical Trials on Early reversal of temporary ileostomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe