SurgeryRAAC-APNCT03552913
Enhanced Recovery After Surgery for Total Knee Arthroplasty, Left Colectomy and Hysterectomy
An observational study of Surgery and Total Knee Arthroplasty, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgery, Total Knee Arthroplasty, Colectomy
- What is being tested?
- 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 and No specific program toward improving practices
- Type of treatment
- Surgery or procedure
- How many people
- 1,710 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jul 2017to Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patient aged > 18 years;
- Resident in France;
- Patient who underwent surgery in 2015 or 2017
Who cannot join
- Patient operated in emergency.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service d'anesthésie-réanimation chirurgicale, Hopital Ambroise Paré
Boulogne-Billancourt, Hauts-de-seine, 92100
Dominique Fletcher, MD, +33 1 49 09 54 23, dominique.fletcher@aphp.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Surgery, Total Knee Arthroplasty, Colectomy, Hysterectomy
- Being tested
- 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, No specific program toward improving practices
- Keywords
- Enhanced Recovery After Surgery, Fast track, Surgery, Hysterectomy, Left colectomy, Total knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One year before awareness-raising phase in favour of Enhanced Recovery After SurgeryProcedure or 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 SurgeryProcedure or surgery
One year after awareness-raising phase in favour of Enhanced Recovery After Surgery
No specific program toward improving practicesProcedure or surgery
No specific program toward improving practices
| Study group | Role | What they receive |
|---|---|---|
| 2015 Total knee arthroplasty, hysterectomy or left colectomy | Group of patients having a total knee arthroplasty, hysterectomy or left colectomy in 2015 Receives: Procedure: 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 Receives: Procedure: 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 Receives: Procedure: 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 Receives: Procedure: No specific program toward improving practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
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.
Measured: through study completion, an average of 1 year
Number of surgery related complications
Benefits on lowering complications rates
Measured: through study completion, an average of 1 year
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start6 Jul 2017
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,710 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique Fletcher, MD, PhD, Principal investigator, Service d'anesthésie-réanimation chirurgicale, Hôpital Ambroise Paré
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03552913
- Sponsor's protocol ID
- CRCCH16001
- Acronym
- RAAC-AP
- Status last verified
- May 2018
- First submitted
- 2 Feb 2018
- Last updated
- 12 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Surgery for Total Knee Arthroplasty, Left Colectomy and Hysterectomy: A Multicenter Study Assessing Care Practice and Prevention
- ClinicalTrials.gov ID
- NCT03552913
- Acronym / sponsor ID
- RAAC-AP / CRCCH16001
- Conditions
- Surgery, Total Knee Arthroplasty, Colectomy, Hysterectomy
- Keywords
- Enhanced Recovery After Surgery, Fast track, Surgery, Hysterectomy, Left colectomy, Total knee arthroplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,710 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 6 Jul 2017 (actual)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 12 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2015 Total knee arthroplasty, hysterectomy or left colectomy | – | Procedure: One year before awareness-raising phase in favour of Enhanced Recovery After SurgeryGroup of patients having a total knee arthroplasty, hysterectomy or left colectomy in 2015 |
| 2017 Total knee arthroplasty, hysterectomy or left colectomy | – | Procedure: One year after awareness-raising phase in favour of Enhanced Recovery After SurgeryGroup of patients having a total knee arthroplasty, hysterectomy or left colectomy in 2017 |
| 2015 Total hip prosthesis, ovariectomy or gastrectomy | – | Procedure: No specific program toward improving practicesGroup of patients having total hip prosthesis, ovariectomy or gastrectomy in 2015 |
| 2017 Total hip prosthesis, ovariectomy or gastrectomy | – | Procedure: No specific program toward improving practicesGroup of patients having total hip prosthesis, ovariectomy or gastrectomy in 2017 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patient aged > 18 years;
- Resident in France;
- Patient who underwent surgery in 2015 or 2017
Key exclusion criteria (1 listed)
- Patient operated in emergency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One year before awareness-raising phase in favour of Enhanced Recovery After SurgeryOne year before awareness-raising phase in favour of Enhanced Recovery After Surgery | Procedure or surgery | 2015 Total knee arthroplasty, hysterectomy or left colectomy |
| One year after awareness-raising phase in favour of Enhanced Recovery After SurgeryOne year after awareness-raising phase in favour of Enhanced Recovery After Surgery | Procedure or surgery | 2017 Total knee arthroplasty, hysterectomy or left colectomy |
| No specific program toward improving practicesNo specific program toward improving practices | Procedure or surgery | 2015 Total hip prosthesis, ovariectomy or gastrectomy, 2017 Total hip prosthesis, ovariectomy or gastrectomy |
Primary outcome
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.
3 secondary outcomes
Compliance with modalities of Enhanced Recovery After Surgery program
Time frame: through study completion, an average of 1 year
Number of surgery related complications
Time frame: through study completion, an average of 1 year
Costs per patient
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique Fletcher, MD, PhD principal investigator
Service d'anesthésie-réanimation chirurgicale, Hôpital Ambroise Paré
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Total Knee Arthroplasty, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominique Fletcher, MD, PhD (+33 1 49 09 54 23, dominique.fletcher@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of hospital stay (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2018.