Enhanced Recovery After Surgery for Total Knee Arthroplasty, Left Colectomy and Hysterectomy

Surgery Clinical Trial

— RAAC-AP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03552913
• Other study ID #: CRCCH16001
• Status: Recruiting
• Start date: July 6, 2017
• Est. completion date: July 2018

Study information

• Verified date: May 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Dominique Fletcher, MD, PhD
• Phone: +33 1 49 09 54 23
• Email: dominique.fletcher[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1710
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion criteria:

• Patient aged > 18 years;

• Resident in France;

• Patient who underwent surgery in 2015 or 2017

Exclusion criteria:

• Patient operated in emergency.

Related Conditions & MeSH terms

• Colectomy
• Hysterectomy
• Surgery
• Total Knee Arthroplasty

Intervention

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
• 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
• No specific program toward improving practices
No specific program toward improving practices

Locations

Country	Name	City	State
France	Service d'anesthésie-réanimation chirurgicale, Hopital Ambroise Paré	Boulogne-Billancourt	Hauts-de-seine

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Compliance with modalities of Enhanced Recovery After Surgery program	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
Secondary	Number of surgery related complications	Benefits on lowering complications rates	through study completion, an average of 1 year
Secondary	Costs per patient	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