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

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ClinicalTrials.gov Identifier: NCT03552913
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment
Surgery Total Knee Arthroplasty Colectomy Hysterectomy Procedure: One year before awareness-raising phase in favour of Enhanced Recovery After Surgery Procedure: One year after awareness-raising phase in favour of Enhanced Recovery After Surgery Procedure: No specific program toward improving practices

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.


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Study Type : Observational
Estimated Enrollment : 1710 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Enhanced Recovery After Surgery for Total Knee Arthroplasty, Left Colectomy and Hysterectomy: A Multicenter Study Assessing Care Practice and Prevention
Actual Study Start Date : July 6, 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Number of surgery related complications [ Time Frame: through study completion, an average of 1 year ]
    Benefits on lowering complications rates

  3. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion criteria:

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

Exclusion criteria:

  • Patient operated in emergency.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552913


Contacts
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Contact: Dominique Fletcher, MD, PhD +33 1 49 09 54 23 dominique.fletcher@aphp.fr
Contact: Anissa Belbachir, MD +33 1 58 41 15 17 anissa.belbachir@aphp.fr

Locations
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France
Service d'anesthésie-réanimation chirurgicale, Hopital Ambroise Paré Recruiting
Boulogne-Billancourt, Hauts-de-seine, France, 92100
Contact: Dominique Fletcher, MD    +33 1 49 09 54 23    dominique.fletcher@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Dominique Fletcher, MD, PhD Service d'anesthésie-réanimation chirurgicale, Hôpital Ambroise Paré

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03552913     History of Changes
Other Study ID Numbers: CRCCH16001
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Enhanced Recovery After Surgery
Fast track
Surgery
Hysterectomy
Left colectomy
Total knee arthroplasty