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NCT01610726 Clinical Trial

Economic and Clinical Evaluation of Enhanced Recovery in Colorectal Surgery

Colonic Diseases Clinical Trial

Official title:
Economic and Clinical Evaluation of Enhanced Recovery in Colorectal Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01610726
Other study ID # 2010/2079
Secondary ID
Status Completed
Phase N/A
First received May 31, 2012
Last updated November 3, 2017
Start date February 2012
Est. completion date December 2016

Study information
Verified date November 2017
Source Haukeland University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the health cost and clinical outcome by introducing enhanced recovery (ERAS) compared to conventional recovery in colorectal surgery.

Description:

Aim of the sudy:

1. Clinical evaluation: To investigate if patients treated with enhanced recovery have a shorter hospital stay and less morbidity than the patients treated conventionally. Other clinical questions witch might be answered in this study are clinical surgical stress response (insulin resistent), amount of analgetics used and time to normal activity.

2. Evaluation of quality of life: Instruments used in this sudy to evaluate quality of life are 15 D and qualitative interview.

3. Economic evaluation: Cost-utility analysis of the clinical studies

4. Compare patients who received a fast track program with dedicated fast track- and stoma nurse specialist and special focus on counselling and stoma education, compared with patients receiving existing current practice of stoma-education in a traditional care pathway, could reduce the length of hospital stay, readmission and stoma related complications

5. Further we will tray to generate additional insights into the impact of counselling when groups of patients are otherwise equal in terms of fast-track criteria. We are therefore continuing the enrolling of our colorectal patients in which both study arms contain the same ERAS items; the arms will only differ in terms of perioperative information and guidance as well as follow-up by dedicated nurses.

Recruitment information / eligibility
Status Completed
Enrollment 484
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Planed elective colorectal surgery, written consent and age above 18 years

Exclusion Criteria:

- Patients below 18 years, pregnancy, surgical emergency and no informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Enhanced versus conventional recovery in colorectal surgery
Enhanced recovery (extended informations to the patients, change of anesthetic procedure, intravenous versus gas, and intensified mobilisation) versus conventional recovery

Locations
Country Name City State
Norway Helse Bergen, Haukeland University Hospital Bergen

Sponsors (1)
Lead Sponsor Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Length of stay 30 days
Secondary Morbidity 30 days
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