NCT03620851

Brief Summary

Comparison of the efficiency of enhanced recovery program after colorectal surgery in elderly patients (≥ 70 yo) and younger patients (\< 70 yo). Efficiency will be rated as a function of length of hospital stay, postoperative complications (medical and surgical, as well as adherence to protocol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
302

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

July 18, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 8, 2018

Completed
24 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

November 20, 2018

Status Verified

November 1, 2018

Enrollment Period

29 days

First QC Date

July 18, 2018

Last Update Submit

November 18, 2018

Conditions

Keywords

enhanced recovery programcolorectal surgeryelderly

Outcome Measures

Primary Outcomes (1)

  • length of hospital stay after colorectal surgery (day)

    The duration of hospitalization is defined as the numberof days the patient stays in the hospital between the day of his surgery and the day of his discharge from the hospital

    through study completion, an average of 1 month

Secondary Outcomes (2)

  • postoperative complications after colorectal surgery

    through study completion, an average of 1 month

  • adherence to the enhanced recovery program

    through study completion, an average of 1 month

Study Arms (1)

elderly patients (≥70 yo) vs. younger patients (<70 yo)

elderly patients (≥ 70 yo) and younger patients (\< 70 yo)

Other: effect of age

Interventions

effect of age on the efficiency of enhanced recovery program

elderly patients (≥70 yo) vs. younger patients (<70 yo)

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients scheduled for colorectal surgery have been included in an enhanced recovery program (ERP) since the 1st November 2015. Preoperative characteristics, surgical and anesthetic data, as well postoperative parameters and complications have been entered prospectively in the GRACE (Groupe francophone de Réhabilitataion Améliorée après ChirurgiE)

You may qualify if:

  • All patients scheduled for colorectal surgery since November 2015

You may not qualify if:

  • Emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Liége

Liège, Belgium

Location

Related Publications (1)

  • Joris J, Hans G, Coimbra C, Decker E, Kaba A. Elderly patients over 70 years benefit from enhanced recovery programme after colorectal surgery as much as younger patients. J Visc Surg. 2020 Feb;157(1):23-31. doi: 10.1016/j.jviscsurg.2019.07.011. Epub 2019 Jul 31.

Study Officials

  • Jean L Joris, MD

    CHU Liege, Belgium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Anesthesiology

Study Record Dates

First Submitted

July 18, 2018

First Posted

August 8, 2018

Study Start

September 1, 2018

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

November 20, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations