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CompletedNCT01610726Updated Nov 7, 2017

Economic and Clinical Evaluation of Enhanced Recovery in Colorectal Surgery

An interventional study of Enhanced versus conventional recovery in colorectal surgery in Colonic Diseases, sponsored by Haukeland University Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-07.

Sponsored by Haukeland University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
484
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
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Conditions studied

  • Colonic Diseases

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Keywords

  • colon
  • rectum
  • recovery
  • surgery
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In context

Colonic Diseases

142 studies on the registry are indexed under Colonic Diseases; 22 are open to participants now.

This study's enrollment of 484 is above the median of 143 across 93 interventional studies indexed under Colonic Diseases.

Browse Colonic Diseases studies →

Lead sponsor

Haukeland University Hospital is the lead sponsor of 276 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Planed elective colorectal surgery, written consent and age above 18 years

Exclusion criteria

Exclusion Criteria:

  • Patients below 18 years, pregnancy, surgical emergency and no informed consent
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
484 participants (actual)

Study arms

  • Active comparator
    enhanced recovery

    Procedure: Enhanced versus conventional recovery in colorectal surgery

  • No intervention
    conventional recovery

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

    Also known as: ERAS, Fast track surgery

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What researchers measure

Primary outcomes

  1. Length of stay

    Time frame: 30 days

Secondary outcomes

  1. Morbidity

    Time frame: 30 days

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Study locations

1 site
  • Helse Bergen, Haukeland University Hospital
    Bergen, 5021, Norway
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References and documents

Publications

  • Forsmo HM, Erichsen C, Rasdal A, Tvinnereim JM, Korner H, Pfeffer F. Randomized Controlled Trial of Extended Perioperative Counseling in Enhanced Recovery After Colorectal Surgery. Dis Colon Rectum. 2018 Jun;61(6):724-732. doi: 10.1097/DCR.0000000000001007. PubMed 29664800 ↗

Individual participant data

Plan to share: Yes

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01610726
Lead sponsor
Haukeland University Hospital
Responsible party
Sponsor
First posted
Jun 4, 2012
Start date
Feb 2012
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Nov 7, 2017

Study contacts

Christian Erichsen, PhD
study chair · Helse Bergen, Haukeland University Hospital
Håvard Forsmo, MD
study chair · Helse Bergen, Haukeland University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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