Economic and Clinical Evaluation of Enhanced Recovery in Colorectal Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Haukeland University Hospital
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01610726
First received: May 31, 2012
Last updated: July 7, 2013
Last verified: July 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Morbidity [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: February 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01610726

Contacts
Contact: Christian Erichsen, PhD +47 55975000 christian.erichsen@helse-bergen.no
Contact: Håvard Forsmo, MD +47 5597500 havard.forsmo@helse-bergen.no

Locations
Norway
Helse Bergen, Haukeland University Hospital Recruiting
Bergen, Norway, 5021
Contact: Christian Erichsen, PhD    +47 55975000    christian.erichsen@helse-bergen.no   
Contact: Håvard Forsmo, MD    +47    havard.forsmo@helse-bergen.no   
Principal Investigator: Christian Erichsen, PhD         
Principal Investigator: Håvard Forsmo, MD         
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

No publications provided

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01610726     History of Changes
Other Study ID Numbers: 2010/2079
Study First Received: May 31, 2012
Last Updated: July 7, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Haukeland University Hospital:
colon
rectum
recovery
surgery

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

ClinicalTrials.gov processed this record on August 26, 2014