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

Anterior Cruciate Ligament Clinical Trial

— DIDTGENOU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02895607
• Other study ID #: DIDTGENOU
• Status: Completed
• Start date: December 2014
• Est. completion date: May 2015

Study information

• Verified date: September 2016
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament

Intervention

Procedure:
• Ambulatory care among eligible patients
The management of Anterior Cruciate Ligament (ACL) Reconstruction 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 in CA (ambulatory surgery) or HC (conventional hospitalization).

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint Joseph	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of pain by visual analogue scale VAS	Evaluation of pain by visual analogue scale (VAS was numerical scale from 0 = no pain to 10 = unbearable pain)	Day 45
Secondary	Assessment of sleep quality	Quality sleep (ENS = 0 = 10 complete insomnia deep sleep without interruption)	Day 45
Secondary	Assessment of Patient satisfaction	Patient satisfaction (ENS 0 = very dissatisfied to 10 = very satisfied)	Day 45