Economic and Clinical Evaluation of Enhanced Recovery in Colorectal Surgery

Not Applicable

Completed

• Conditions: Colonic Diseases
• Interventions: Procedure: Enhanced versus conventional recovery in colorectal surgery

• Registration Number: NCT01610726
• Lead Sponsor: Haukeland University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-05-31
• Study First Submitted QC: 2012-05-31
• Study First Posted: 2012-06-04
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-03
• Last Update Posted: 2017-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 484

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
enhanced recovery	Enhanced versus conventional recovery in colorectal surgery	-

Primary Outcome Measures

Name	Time	Method
Length of stay	30 days

Secondary Outcome Measures

Name	Time	Method
Morbidity	30 days

Trial Locations

Locations (1)

Helse Bergen, Haukeland University Hospital; 🇳🇴 Bergen, Norway