NCT03552913

Brief Summary

The objective of the study is to assess retrospectively the effect of an awareness-raising phase in favour of Enhanced Recovery After Surgery across the Assistance Publique-Hopitaux Paris institution and to explore the determinants of compliance with modalities of Enhanced Recovery After Surgery. This multicenter study is performed for three types of surgery: total knee arthroplasty, left colectomy and hysterectomy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,710

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

July 6, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 12, 2018

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

June 12, 2018

Status Verified

May 1, 2018

Enrollment Period

12 months

First QC Date

February 2, 2018

Last Update Submit

June 10, 2018

Conditions

SurgeryTotal Knee ArthroplastyColectomyHysterectomy

Keywords

Enhanced Recovery After SurgeryFast trackSurgeryHysterectomyLeft colectomyTotal knee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Duration of hospital stay

    The average duration of hospital stay will be compared for the year before (2015) and following (2017) the awareness-raising program implemented in 2016 for patients with knee arthroplasty, hysterectomy or left colectomy.

    through study completion, an average of 1 year

Secondary Outcomes (3)

  • Compliance with modalities of Enhanced Recovery After Surgery program

    through study completion, an average of 1 year

  • Number of surgery related complications

    through study completion, an average of 1 year

  • Costs per patient

    through study completion, an average of 1 year

Study Arms (4)

2015 Total knee arthroplasty, hysterectomy or left colectomy

Group of patients having a total knee arthroplasty, hysterectomy or left colectomy in 2015

Procedure: One year before awareness-raising phase in favour of Enhanced Recovery After Surgery

2017 Total knee arthroplasty, hysterectomy or left colectomy

Group of patients having a total knee arthroplasty, hysterectomy or left colectomy in 2017

Procedure: One year after awareness-raising phase in favour of Enhanced Recovery After Surgery

2015 Total hip prosthesis, ovariectomy or gastrectomy

Group of patients having total hip prosthesis, ovariectomy or gastrectomy in 2015

Procedure: No specific program toward improving practices

2017 Total hip prosthesis, ovariectomy or gastrectomy

Group of patients having total hip prosthesis, ovariectomy or gastrectomy in 2017

Procedure: No specific program toward improving practices

Interventions

One year before awareness-raising phase in favour of Enhanced Recovery After SurgeryPROCEDURE

One year before awareness-raising phase in favour of Enhanced Recovery After Surgery

2015 Total knee arthroplasty, hysterectomy or left colectomy
One year after awareness-raising phase in favour of Enhanced Recovery After SurgeryPROCEDURE

One year after awareness-raising phase in favour of Enhanced Recovery After Surgery

2017 Total knee arthroplasty, hysterectomy or left colectomy
No specific program toward improving practicesPROCEDURE

No specific program toward improving practices

2015 Total hip prosthesis, ovariectomy or gastrectomy2017 Total hip prosthesis, ovariectomy or gastrectomy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients who underwent surgery (total knee arthroplasty, colectomy, hysterectomy and total hip prosthesis, ovariectomy or gastrectomy for the control groups) in 2015 or 2017.

You may qualify if:

  • Patient aged \> 18 years;
  • Resident in France;
  • Patient who underwent surgery in 2015 or 2017

You may not qualify if:

  • Patient operated in emergency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'anesthésie-réanimation chirurgicale, Hopital Ambroise Paré

Boulogne-Billancourt, Hauts-de-seine, 92100, France

RECRUITING

Study Officials

  • Dominique Fletcher, MD, PhD

    Service d'anesthésie-réanimation chirurgicale, Hôpital Ambroise Paré

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique Fletcher, MD, PhD

CONTACT

+33 1 49 09 54 23dominique.fletcher@aphp.fr

Anissa Belbachir, MD

CONTACT

+33 1 58 41 15 17anissa.belbachir@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2018

First Posted

June 12, 2018

Study Start

July 6, 2017

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

June 12, 2018

Record last verified: 2018-05

Locations

FR(1)