Economic and Clinical Evaluation of Enhanced Recovery in Colorectal Surgery

Study Overview
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Brief Summary
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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
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Aim of the sudy: 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. Evaluation of quality of life: Instruments used in this sudy to evaluate quality of life are 15 D and qualitative interview. Economic evaluation: Cost-utility analysis of the clinical studies 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 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.

Official Title
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Economic and Clinical Evaluation of Enhanced Recovery in Colorectal Surgery

Conditions
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Colonic Diseases

Intervention / Treatment
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* Procedure: Enhanced versus conventional recovery in colorectal surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: enhanced recovery<br> | Procedure: Enhanced versus conventional recovery in colorectal surgery<br>* Enhanced recovery (extended informations to the patients, change of anesthetic procedure, intravenous versus gas, and intensified mobilisation) versus conventional recovery<br>* Other names: Fast track surgery;|
| No Intervention: conventional recovery<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colon, rectum, recovery, surgery