Early Closure of Temporary Ileostomy (EASY)
This study is currently recruiting participants.
Verified March 2013 by Herlev Hospital
Sponsor:
Herlev Hospital
Information provided by (Responsible Party):
Anne Kjærgaard Danielsen, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01287637
First received: January 28, 2011
Last updated: March 4, 2013
Last verified: March 2013
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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 |
Resource links provided by NLM:
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: | 200 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2013 (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 200 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01287637
Contacts
| Contact: Anne K. Danielsen, ph.d.student | 0045 38682412 | anne.kjaergaard.danielsen@regionh.dk |
Locations
| Denmark | |
| Herlev Hospital, University of Copenhagen | Recruiting |
| Herlev, Denmark, 2730 | |
| Principal Investigator: Anne K. Danielsen, RN | |
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: | Anne Kjærgaard Danielsen, Ph.d.student, RN, Herlev Hospital |
| ClinicalTrials.gov Identifier: | NCT01287637 History of Changes |
| Other Study ID Numbers: | AKD03 |
| Study First Received: | January 28, 2011 |
| Last Updated: | March 4, 2013 |
| Health Authority: | Denmark: Danish Dataprotection Agency |
Keywords provided by Herlev Hospital:
|
Rectal cancer Temporary ileostomy Ealy reversal Morbidity |
Mortality Quality of life Economic effect |
Additional relevant MeSH terms:
|
Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 23, 2013