Rectal Cancer
Conditions
Keywords
Rectal cancer, Temporary ileostomy, Ealy reversal, Morbidity, Mortality, Quality of life, Economic effect
Brief summary
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
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.
Interventions
PROCEDUREEarly reversal of temporary ileostomy
Temporary ileostomy is reversed 8-13 days after the primary surgery
PROCEDUREStandard 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
Sponsors
Herlev Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postsurgical morbidity | 3 months after inclusion | Patients are scored according to the Clavien-Dindo Classification of Surgical Complications. |
| Postsurgical morbidity. | 12 months after inclusion- | Patients are scored according to the Clavien-Dindo Classification of Surgical Complications. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 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) |
| Socio-economic effect of early reversal of temporary ileostomy | 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. |
Countries
Denmark
Outcome results
None listed