Economic and Clinical Evaluation of Enhanced Recovery in Colorectal Surgery
Primary Purpose
Colonic Diseases
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Enhanced versus conventional recovery in colorectal surgery
Sponsored by
About this trial
This is an interventional treatment trial for Colonic Diseases focused on measuring colon, rectum, recovery, surgery
Eligibility Criteria
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
Sites / Locations
- Helse Bergen, Haukeland University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
enhanced recovery
conventional recovery
Arm Description
Outcomes
Primary Outcome Measures
Length of stay
Secondary Outcome Measures
Morbidity
Full Information
NCT ID
NCT01610726
First Posted
May 31, 2012
Last Updated
November 3, 2017
Sponsor
Haukeland University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01610726
Brief Title
Economic and Clinical Evaluation of Enhanced Recovery in Colorectal Surgery
Official Title
Economic and Clinical Evaluation of Enhanced Recovery in Colorectal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Diseases
Keywords
colon, rectum, recovery, surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
484 (Actual)
8. Arms, Groups, and Interventions
Arm Title
enhanced recovery
Arm Type
Active Comparator
Arm Title
conventional recovery
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Enhanced versus conventional recovery in colorectal surgery
Other Intervention Name(s)
ERAS, Fast track surgery
Intervention Description
Enhanced recovery (extended informations to the patients, change of anesthetic procedure, intravenous versus gas, and intensified mobilisation) versus conventional recovery
Primary Outcome Measure Information:
Title
Length of stay
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Morbidity
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Erichsen, PhD
Organizational Affiliation
Helse Bergen, Haukeland University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Håvard Forsmo, MD
Organizational Affiliation
Helse Bergen, Haukeland University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Helse Bergen, Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
29664800
Citation
Forsmo HM, Erichsen C, Rasdal A, Tvinnereim JM, Korner H, Pfeffer F. Randomized Controlled Trial of Extended Perioperative Counseling in Enhanced Recovery After Colorectal Surgery. Dis Colon Rectum. 2018 Jun;61(6):724-732. doi: 10.1097/DCR.0000000000001007.
Results Reference
derived
Learn more about this trial
Economic and Clinical Evaluation of Enhanced Recovery in Colorectal Surgery
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