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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early reversal group | Experimental | Early reversal of temporary ileostomy |
|
| Control group | Active Comparator | Standard reversal of temporary ileostomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early reversal of temporary ileostomy | Procedure | Temporary ileostomy is reversed 8-13 days after the primary surgery |
|
| 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- |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacob Rosenberg, Professor | Herlev Hospital, University of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev Hospital, University of Copenhagen | Herlev | 2730 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30911920 | Derived | Park J, Angenete E, Bock D, Correa-Marinez A, Danielsen AK, Gehrman J, Haglind E, Jansen JE, Skullman S, Wedin A, Rosenberg J. Cost analysis in a randomized trial of early closure of a temporary ileostomy after rectal resection for cancer (EASY trial). Surg Endosc. 2020 Jan;34(1):69-76. doi: 10.1007/s00464-019-06732-y. Epub 2019 Mar 25. | |
| 29168881 |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D011184 | Postoperative Period |
| ID | Term |
|---|---|
| D059035 | Perioperative Period |
| D013514 | Surgical Procedures, Operative |
| D005791 | Patient Care |
| D006296 | Health Services |
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| Standard reversal of temporary ileostomy | Procedure | Patients in the control group will have the ileostomy reversed according to standard treatment, which is 12-26 weeks after primary operation |
|
|
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 |
| Park J, Danielsen AK, Angenete E, Bock D, Marinez AC, Haglind E, Jansen JE, Skullman S, Wedin A, Rosenberg J. Quality of life in a randomized trial of early closure of temporary ileostomy after rectal resection for cancer (EASY trial). Br J Surg. 2018 Feb;105(3):244-251. doi: 10.1002/bjs.10680. Epub 2017 Nov 23. |
| 27322187 | Derived | Danielsen AK, Park J, Jansen JE, Bock D, Skullman S, Wedin A, Marinez AC, Haglind E, Angenete E, Rosenberg J. Early Closure of a Temporary Ileostomy in Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial. Ann Surg. 2017 Feb;265(2):284-290. doi: 10.1097/SLA.0000000000001829. |
| 22021780 | Derived | Danielsen AK, Correa-Marinez A, Angenete E, Skullmann S, Haglind E, Rosenberg J; SSORG (Scandinavian Outcomes Research Group). Early closure of temporary ileostomy--the EASY trial: protocol for a randomised controlled trial. BMJ Open. 2011 Jul 29;1(1):e000162. doi: 10.1136/bmjopen-2011-000162. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D005159 |
| Health Care Facilities Workforce and Services |