Early Closure of Temporary Ileostomy (EASY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Herlev Hospital
Sponsor:
Information provided by (Responsible Party):
Helle Birgitte Kjeldsen, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01287637
First received: January 28, 2011
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention
Rectal Cancer
Procedure: Early reversal of temporary ileostomy
Procedure: Standard reversal of temporary ileostomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Closure of Temporary Ileostomy- a Randomized Clinical Trial

Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Postsurgical morbidity [ Time Frame: 3 months after inclusion ] [ Designated as safety issue: Yes ]
    Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.

  • Postsurgical morbidity [ Time Frame: 6 months after inclusion ] [ Designated as safety issue: Yes ]
    Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.

  • Postsurgical morbidity. [ Time Frame: 12 months after inclusion- ] [ Designated as safety issue: Yes ]
    Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.


Secondary Outcome Measures:
  • Quality of life [ Time Frame: Quality of life is assessed at 3 months after inclusion ] [ Designated as safety issue: No ]
    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 [ Time Frame: Quality of life is assessed at 6 months after inclusion ] [ Designated as safety issue: No ]
    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 [ Time Frame: Quality of life is assessed at 12 months after inclusion ] [ Designated as safety issue: No ]
    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)

  • Socio-economic effect of early reversal of temporary ileostomy [ Time Frame: The investigators assess and analyze the economic effect 6 months after inclusion ] [ Designated as safety issue: No ]
    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.

  • Socio-economic effect of early reversal of temporary ileostomy [ Time Frame: The investigators assess and analyze the economic effect 12 months after inclusion ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 144
Study Start Date: February 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: stoma reversal 12-26 weeks after stoma creation

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 144 patients over an expected period of 1 year. Both groups are examined for postoperative 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01287637

Contacts
Contact: Helle B. Kjeldsen, research nurse 0045 38689435 Helle.Birgitte.Kjelsen@regionh.dk

Locations
Denmark
Herlev Hospital, University of Copenhagen Recruiting
Herlev, Denmark, 2730
Principal Investigator: Helle B. Kjeldsen, RN, Ma(NSc)         
Sponsors and Collaborators
Herlev Hospital
Investigators
Principal Investigator: Jacob Rosenberg, Professor Herlev Hospital, University of Copenhagen
  More Information

No publications provided by Herlev Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Helle Birgitte Kjeldsen, Research Nurse, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01287637     History of Changes
Other Study ID Numbers: AKD03
Study First Received: January 28, 2011
Last Updated: April 1, 2014
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Herlev Hospital:
Rectal cancer
Temporary ileostomy
Ealy reversal
Morbidity
Mortality
Quality of life
Economic effect

ClinicalTrials.gov processed this record on October 22, 2014