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Economic and Clinical Evaluation of Enhanced Recovery in Colorectal Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01610726
First Posted: June 4, 2012
Last Update Posted: November 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Haukeland University Hospital
  Purpose
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 Intervention
Colonic Diseases Procedure: Enhanced versus conventional recovery in colorectal surgery

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

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

Secondary Outcome Measures:
  • Morbidity [ Time Frame: 30 days ]

Enrollment: 484
Study Start Date: February 2012
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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


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

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01610726     History of Changes
Other Study ID Numbers: 2010/2079
First Submitted: May 31, 2012
First Posted: June 4, 2012
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:
colon
rectum
recovery
surgery

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