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Economic and Clinical Evaluation of Enhanced Recovery in Colorectal Surgery

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ClinicalTrials.gov Identifier: NCT01610726
Recruitment Status : Completed
First Posted : June 4, 2012
Last Update Posted : November 7, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Colonic Diseases Procedure: Enhanced versus 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 484 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Economic and Clinical Evaluation of Enhanced Recovery in Colorectal Surgery
Study Start Date : February 2012
Primary Completion Date : December 2016
Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonic Diseases
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: enhanced recovery 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
Other Names:
  • ERAS
  • Fast track surgery
No Intervention: conventional recovery

Primary Outcome Measures :
  1. Length of stay [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Morbidity [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01610726

Helse Bergen, Haukeland University Hospital
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
Study Chair: Christian Erichsen, PhD Helse Bergen, Haukeland University Hospital
Study Chair: Håvard Forsmo, MD Helse Bergen, Haukeland University Hospital

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01610726     History of Changes
Other Study ID Numbers: 2010/2079
First Posted: June 4, 2012    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Haukeland University Hospital:

Additional relevant MeSH terms:
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases