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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 6, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Surgery

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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings