Evaluation of Outpatient Surgery in the Anterior Cruciate Ligament Reconstructions With Hamstring Hospital (DIDTGENOU)

August 9, 2018 updated by: Groupe Hospitalier Paris Saint Joseph

Prospective Evaluation of Outpatient Surgery in the Anterior Cruciate Ligament Reconstructions With Hamstring Hospital

Care in ambulatory surgery (CA) is growing in France, despite lagging behind other countries in North or US Europe. Arthroscopic knee surgery is a minimally invasive surgery eligible for CA. Currently 71.8% of knee arthroscopy are made in this context. However ligamentoplasties anterior cruciate are still carried out predominantly in conventional hospitalization (HC) with a median of 3 to 5.5 days of stay.

Two recent prospective studies French single-operator shows the feasibility of reconstruction of the anterior cruciate ligament (ACL) in ambulatory: no serious events were recorded, the risks are comparable to those of a HC.

However, this support requires a structure and a coordinated network between different medical and paramedical (surgeons, anesthetists, nurse frame, City nurse, doctor, physiotherapist).

The objective of the study is to evaluate (i.e. EPP or "feasibility") ACL reconstruction in CA in hospitals, multi-operator.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

II. objectives

at. primary objective

Rating (or "feasibility") of a management protocol HDJ of ACL reconstruction in a hospital structure on a multi-operator series.

Evaluation criteria (absence of EG)?

b. secondary objectives

i. Evaluation of the acceptance rates of ambulatory care patients eligible

ii. Evaluation of the rate and type of complication in our series

iii. Evaluation of early postoperative results (postoperative pain, analgesic consumption, sleep, satisfaction)

IV. Methodology and duration of the research

This is a consecutive series single-center multi-operator prospective regarding the evaluation of surgical practice cited in goal.

The inclusion of patients will take place over a period of 4 months.

The management of ACL reconstruction in outpatient will be proposed in consultation with the surgeon.

After an explanation of the course of treatment a fact sheet on the protocol will be provided to the patient and his doctor to the patient to decide its support AC or HC.

Clinical data will be collected by telephone the first 4 days and in consultation with J45. The revision sheet is provided.

Patients are aware of the use of their data for medical research through oral information provided by the doctor at the signing by the patient's consent related to the surgery.

The data collected as part of the research are anonymous and unidentifiable (for each subject is assigned a number); the name of the surgeon is also anonymized.

Study Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile-de-France
      • Paris, Ile-de-France, France, 75014
        • Groupe Hospitalier Paris Saint Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients admitted to the orthopedic unit for anterior cruciate ligament (ACL)

Description

Inclusion Criteria:

  • Isolated ACL tear
  • First arthroscopic reconstruction at DIDT

Exclusion Criteria:

  • Age over 60 years
  • ASA score greater than 2
  • Geographical remoteness
  • Social isolation
  • medical condition requiring supervision by HC (phlebitis history, coagulation disorders ...)
  • psychiatric pathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of pain by visual analogue scale VAS
Time Frame: Day 45
Evaluation of pain by visual analogue scale (VAS was numerical scale from 0 = no pain to 10 = unbearable pain)
Day 45

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of sleep quality
Time Frame: Day 45
Quality sleep (ENS = 0 = 10 complete insomnia deep sleep without interruption)
Day 45
Assessment of Patient satisfaction
Time Frame: Day 45
Patient satisfaction (ENS 0 = very dissatisfied to 10 = very satisfied)
Day 45

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Investigators

  • Principal Investigator: Pierre Emmanuel MOREAU, MD, Groupe Hospitalier Paris Saint Joseph

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

September 1, 2016

First Submitted That Met QC Criteria

September 8, 2016

First Posted (Estimate)

September 9, 2016

Study Record Updates

Last Update Posted (Actual)

August 10, 2018

Last Update Submitted That Met QC Criteria

August 9, 2018

Last Verified

September 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • DIDTGENOU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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