Early Closure of Temporary Ileostomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Early Closure of Temporary Ileostomy- a Randomized Clinical Trial

Conditions
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Rectal Cancer

Intervention / Treatment
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* Procedure: Early reversal of temporary ileostomy
* Procedure: Standard reversal of temporary ileostomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rectal cancer, Temporary ileostomy, Ealy reversal, Morbidity, Mortality, Quality of life, Economic effect