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Completed

NCT Number: NCT02895607

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.

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Key information

Conditions

Anterior Cruciate Ligament

Age range

Up to 60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ambulatory care among eligible patients

Procedure

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).

Primary outcomes

  1. 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)

Secondary outcomes

  1. Assessment of sleep quality

    Time frame: Day 45

    Quality sleep (ENS = 0 = 10 complete insomnia deep sleep without interruption)

  2. Assessment of Patient satisfaction

    Time frame: Day 45

    Patient satisfaction (ENS 0 = very dissatisfied to 10 = very satisfied)

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Registry information

Official study title

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

Acronym: DIDTGENOU

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 9, 2016
Registry last updated
Aug 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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