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Economic and Clinical Evaluation of Enhanced Recovery in Colorectal Surgery

Economic and Clinical Evaluation of Enhanced Recovery in Colorectal Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01610726
Enrollment
484
Registered
2012-06-04
Start date
2012-02-29
Completion date
2016-12-31
Last updated
2017-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Diseases

Keywords

colon, rectum, recovery, surgery

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.

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.

Interventions

PROCEDUREEnhanced 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

Sponsors

Haukeland University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Length of stay30 days

Secondary

MeasureTime frame
Morbidity30 days

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026