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

• Conditions: Hysterectomy; Surgery; Total Knee Arthroplasty; Colectomy

• Registration Number: NCT03552913
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-07-06
• Study First Submitted: 2018-02-02
• Status Verified: 2018-05
• Study First Submitted QC: 2018-06-10
• Last Update Submitted: 2018-06-10
• Study First Posted: 2018-06-12
• Last Update Posted: 2018-06-12
• Primary Completion: 2018-07
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1710

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of hospital stay	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

Name	Time	Method
Compliance with modalities of Enhanced Recovery After Surgery program	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.
Costs per patient	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.
Number of surgery related complications	through study completion, an average of 1 year	Benefits on lowering complications rates

Trial Locations

Locations (1)

Service d'anesthésie-réanimation chirurgicale, Hopital Ambroise Paré; 🇫🇷 Boulogne-Billancourt, Hauts-de-seine, France