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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
89

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Herlev Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 1, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings