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Completed

NCT Number: NCT01610726

Economic and Clinical Evaluation of Enhanced Recovery in Colorectal Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helse Bergen, Haukeland University Hospital

Bergen, 5021, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced versus conventional recovery in colorectal surgery

Procedure

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

Primary outcomes

  1. Length of stay

    Time frame: 30 days

Secondary outcomes

  1. Morbidity

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jun 4, 2012
Registry last updated
Nov 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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