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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
89
Temporary ileostomy is reversed 8-13 days after the primary surgery
Patients in the control group will have the ileostomy reversed according to standard treatment, which is 12-26 weeks after primary operation
Herlev Hospital, University of Copenhagen
Herlev, Denmark
Postsurgical morbidity
Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.
Time frame: 3 months after inclusion
Postsurgical morbidity
Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.
Time frame: 6 months after inclusion
Postsurgical morbidity.
Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.
Time frame: 12 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)
Time frame: 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)
Time frame: 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)
Time frame: Quality of life is assessed at 12 months after inclusion
Socio-economic effect of early reversal of temporary ileostomy
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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.
Time frame: 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.
Time frame: The investigators assess and analyze the economic effect 12 months after inclusion