Early Closure of Temporary Ileostomy

Rectal Cancer Clinical Trial

— EASY  

Official title:

Early Closure of Temporary Ileostomy- a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01287637
• Other study ID #: AKD03
• Status: Completed
• Phase: N/A
• First received: January 28, 2011
• Last updated: January 16, 2016
• Start date: February 2011
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer

Intervention

Procedure:
• Early reversal of temporary ileostomy
Temporary ileostomy is reversed 8-13 days after the primary surgery
• 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

Locations

Country	Name	City	State
Denmark	Herlev Hospital, University of Copenhagen	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postsurgical morbidity	Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.	3 months after inclusion	Yes
Primary	Postsurgical morbidity	Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.	6 months after inclusion	Yes
Primary	Postsurgical morbidity.	Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.	12 months after inclusion-	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No