Enhanced Recovery After Surgery for Total Knee Arthroplasty, Left Colectomy and Hysterectomy (RAAC-AP)

June 10, 2018 updated by: Assistance Publique - Hôpitaux de Paris

Enhanced Recovery After Surgery for Total Knee Arthroplasty, Left Colectomy and Hysterectomy: A Multicenter Study Assessing Care Practice and Prevention

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The primary goal of the study is to quantify the effect of an awareness-raising phase in favour of Enhanced Recovery After Surgery which was organized in 2016 within the public hospitals in Paris (Assistance Publique - Hôpitaux de Paris).

The study aims to document and compare the compliance with fast track modalities and its impact for the year before (2015) and the year following (2017) the awareness-raising phase. Durations of hospital stay, compliance with recommendations, benefits on lowering complication rates and cost reductions will be studied for three types of interventions: total knee arthroplasty, left colectomy and hysterectomy.

Preoperative information provided to patients, counselling and physical optimisation will be evaluated through a survey among physicians whereas compliance with pre-, intra- and postoperative patient management guidelines will be retrospectively retrieved from the medical records of randomly selected patients. Survival and hospital trajectories will be obtained through the centralised national medical data system.

Three groups of patients having underwent total hip prosthesis, ovariectomy or gastrectomy in the same years (2015 and 2017) will serve as control groups, as for these surgeries no specific program has been implemented toward any practice change.

Study Type

Observational

Enrollment (Anticipated)

1710

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Hauts-de-seine
      • Boulogne-Billancourt, Hauts-de-seine, France, 92100
        • Recruiting
        • Service d'anesthésie-réanimation chirurgicale, Hopital Ambroise Paré
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability 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.

Description

Inclusion criteria:

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

Exclusion criteria:

  • Patient operated in emergency.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
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
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
No specific program toward improving practices

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of hospital stay
Time Frame: through study completion, an average of 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance with modalities of Enhanced Recovery After Surgery program
Time Frame: through study completion, an average of 1 year
Modalities of Enhanced Recovery After Surgery recommendations will be compared between the year before (2015) and the year following (2017) the awareness-raising program implemented in 2016.
through study completion, an average of 1 year
Number of surgery related complications
Time Frame: through study completion, an average of 1 year
Benefits on lowering complications rates
through study completion, an average of 1 year
Costs per patient
Time Frame: through study completion, an average of 1 year
To determine if the awareness-raising program implemented in 2016 has produced a significant cost per patient reduction. The total cost for hospitalization, readmission and surgery related complications will be assessed.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Dominique Fletcher, MD, PhD, Service d'anesthésie-réanimation chirurgicale, Hopital Ambroise Paré

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2017

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

February 2, 2018

First Submitted That Met QC Criteria

June 10, 2018

First Posted (Actual)

June 12, 2018

Study Record Updates

Last Update Posted (Actual)

June 12, 2018

Last Update Submitted That Met QC Criteria

June 10, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CRCCH16001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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