NCT01610726

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
484

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 4, 2012

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 7, 2017

Status Verified

November 1, 2017

Enrollment Period

4.8 years

First QC Date

May 31, 2012

Last Update Submit

November 3, 2017

Conditions

Colonic Diseases

Keywords

colonrectumrecoverysurgery

Outcome Measures

Primary Outcomes (1)

  • Length of stay

    30 days

Secondary Outcomes (1)

  • Morbidity

    30 days

Study Arms (2)

enhanced recovery

ACTIVE COMPARATOR
Procedure: Enhanced versus conventional recovery in colorectal surgery

conventional recovery

NO INTERVENTION

Interventions

Enhanced versus conventional recovery in colorectal surgeryPROCEDURE

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
enhanced recovery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helse Bergen, Haukeland University Hospital

Bergen, 5021, Norway

Location

Related Publications (1)

  • 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.

    PMID: 29664800DERIVED

MeSH Terms

Conditions

Colonic Diseases

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Christian Erichsen, PhD

    Helse Bergen, Haukeland University Hospital

    STUDY CHAIR

  • Håvard Forsmo, MD

    Helse Bergen, Haukeland University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2012

First Posted

June 4, 2012

Study Start

February 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

November 7, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will share

Locations

NO(1)