Clinical trial NCT03552913: Enhanced Recovery After Surgery for Total Knee Arthroplasty, Left Colectomy and Hysterectomy
Official title: Enhanced Recovery After Surgery for Total Knee Arthroplasty, Left Colectomy and Hysterectomy: A Multicenter Study Assessing Care Practice and Prevention
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgery
Total Knee Arthroplasty
Colectomy
Hysterectomy
Keywords: Enhanced Recovery After Surgery
Fast track
Surgery
Hysterectomy
Left colectomy
Total knee arthroplasty
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 1710
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: Inclusion criteria:

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

Exclusion criteria:

* Patient operated in emergency.

Primary outcomes:
measure: Duration of hospital stay
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Compliance with modalities of Enhanced Recovery After Surgery program
timeFrame: through study completion, an average of 1 year
measure: Number of surgery related complications
timeFrame: through study completion, an average of 1 year
measure: Costs per patient
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Service d'anesthésie-réanimation chirurgicale, Hopital Ambroise Paré
state: Hauts-de-seine
Study officials:
affiliation: Service d'anesthésie-réanimation chirurgicale, Hôpital Ambroise Paré
name: Dominique Fletcher, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: