- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01610726
Economic and Clinical Evaluation of Enhanced Recovery in Colorectal Surgery
November 3, 2017 updated by: Haukeland University Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
484
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bergen, Norway, 5021
- Helse Bergen, Haukeland University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: enhanced recovery
|
Enhanced recovery (extended informations to the patients, change of anesthetic procedure, intravenous versus gas, and intensified mobilisation) versus conventional recovery
Other Names:
|
No Intervention: conventional recovery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Length of stay
Time Frame: 30 days
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Morbidity
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Christian Erichsen, PhD, Helse Bergen, Haukeland University Hospital
- Study Chair: Håvard Forsmo, MD, Helse Bergen, Haukeland University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
May 31, 2012
First Submitted That Met QC Criteria
May 31, 2012
First Posted (Estimate)
June 4, 2012
Study Record Updates
Last Update Posted (Actual)
November 7, 2017
Last Update Submitted That Met QC Criteria
November 3, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010/2079
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colonic Diseases
-
Imperial College LondonCompletedColonic Diseases | Colonic Polyp | Colonic Neoplasms | Colonic Cancer | Colonic Adenocarcinoma | Colonic Adenoma | Colonic Carcinoma | Colonic Dysplasia | Colon Hyperplastic PolypUnited Kingdom
-
Uppsala UniversityCompletedColonic DiverticulitisSweden
-
Uppsala UniversityLandstinget i VärmlandCompleted
-
University of AarhusOdense University Hospital; Aarhus University Hospital; University of Southern... and other collaboratorsRecruiting
-
Oxford University Hospitals NHS TrustCompletedRectal Cancer | Ulcerative Colitis | Colonic Cancer | Colonic DiverticulumUnited Kingdom
-
Changi General HospitalNational University Hospital, Singapore; Singapore General Hospital; Tan Tock...CompletedColonic Polyp | Colonic Neoplasms | Colonic DysplasiaSingapore
-
Hospital Universitario de MóstolesCompletedColonic Polyp | Colonic Neoplasms | Colonic Cancer
-
Universitätsmedizin MannheimTerminatedColo-colonic Anastomoses | Ileo-colonic AnastomosesGermany
-
Odense University HospitalEnrolling by invitationDiverticulitis, ColonicDenmark
-
University of Turin, ItalyNot yet recruitingColonic Polyp | Colonic Neoplasms | Colonic Dysplasia
Clinical Trials on Enhanced versus conventional recovery in colorectal surgery
-
Assiut UniversityCompleted
-
The Affiliated Hospital of Qingdao UniversityCompleted
-
Instituto Brasileiro de Controle do CancerWithdrawnEnhanced Recovery After Surgery | Gynecologic Surgical ProceduresBrazil
-
Instituto Brasileiro de Controle do CancerRecruitingGynecologic Cancer | Enhanced Recovery After SurgeryBrazil
-
The Second Hospital of Shandong UniversityRecruitingLung Cancer | Surgery | ERASChina
-
Services Hospital, LahoreCompletedEnhanced Recovery After SurgeryPakistan
-
Chonnam National University HospitalCompleted
-
University of Colorado, DenverRecruitingEnhanced Recovery After Surgery | Gynecologic DiseaseUnited States
-
Assistance Publique - Hôpitaux de ParisUnknownSurgery | Total Knee Arthroplasty | Colectomy | HysterectomyFrance
-
Shanghai 6th People's HospitalNot yet recruitingTraumatic Brain Injury | Cerebrovascular Disease | Neurocritical Care | Moderate or Severe ComaChina