ERAS on Cervical Surgery
Evaluation of the Effect of Enhanced Recovery After Surgery for Cervical Surgery
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
To evaluate the effect of a series of optimization measures in ERAS among the patients during perioperative period who underwent cervical surgery.
Methods:
A retrospective cohort study was conducted for the patients who underwent cervical spine surgery in a top three hospital in Beijing from April to December 2018. According to whether to implement enhanced recovery surgery, the patients were divided into enhanced recovery surgery group (eras group) and control group. The self-designed data collection table was used to collect data in the patient's medical records, including general demographic data and disease treatment data, implementation of accelerated rehabilitation surgery and application effect. Among them, the application effect includes the operation related complications, the visual analog scale (VAS) score of neck and shoulder pain, the ability of daily living after discharge, the length of stay, the cost of hospitalization and other recent rehabilitation effect indicators, as well as the rehospitalization rate of 90 days and the Japanese Orthopaedic Society four months after operation Association (JOA) score, neck disability index (NDI) score, neck and shoulder pain symptoms, neck and shoulder stiffness symptoms and other long-term rehabilitation indicators. Independent sample t-test, rank sum test and chi square test were used to compare the differences between the two groups. On the basis of single factor analysis, combined with multi factor analysis, the impact of groups on outcome indicators was clarified, included 90-day readmission, reexamination time, follow-up JOA score, NDI score, neck and shoulder pain symptoms and neck and shoulder stiffness symptoms.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
Beijing
-
Beijing, Beijing, Cina, 100083
- Peking University Third Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- ① patients with cervical spondylosis were definitely diagnosed; ② Cervical spine surgery was performed under general anesthesia; ③ Age ≥ 18 years old;
Exclusion Criteria:
- ① patients with cervical deformity correction surgery; ② Patients who underwent secondary cervical spine surgery; ③ Patients with spinal cord injury caused by trauma (4) patients with thoracic and atlantoaxial diseases and corresponding surgery; ⑤ Ankylosing spondylitis patients; ⑥ Patients with cerebral infarction, cerebral palsy and nerve root injury.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
ERAS Group
Patients were treated by enhanced recovery after surgery
|
La gestione ERAS comprende 3 parti: (1) Analgesia preoperatoria e valutazione delle vie aeree.
(2) La protezione e la ricostruzione del complesso muscolo-legamentoso durante l'intervento chirurgico, l'intubazione sicura e l'anestesia locale di infiltrazione durante l'intervento chirurgico.
(3) Analgesia senza collare, multimodale, gestione delle vie aeree e recupero precoce dopo l'intervento chirurgico.
|
|
Control Group
Patients were not treated by enhanced recovery after surgery
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
the ability of daily living
Lasso di tempo: Baseline
|
The medical history related to the ability of daily living
|
Baseline
|
|
the ability of daily living
Lasso di tempo: 90-day follow-up after surgery
|
The medical history related to the ability of daily living
|
90-day follow-up after surgery
|
|
the length of hospital stay
Lasso di tempo: Admission to discharge, an average of 3 days
|
the length of hospital stay
|
Admission to discharge, an average of 3 days
|
|
the cost of hospitalization
Lasso di tempo: Admission to discharge, an average of 3 days
|
the cost of hospitalization
|
Admission to discharge, an average of 3 days
|
|
the rehospitalization rate
Lasso di tempo: 90-day follow-up after surgery
|
the rehospitalization rate of 90 days
|
90-day follow-up after surgery
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
VAS (visual analog scale ) score
Lasso di tempo: Baseline
|
VAS score of neck and shoulder pain, 0-100 points, higher means worse outcomes
|
Baseline
|
|
VAS (visual analog scale ) score
Lasso di tempo: 90-day follow-up after surgery
|
VAS score of neck and shoulder pain, 0-100 points, higher means worse outcomes
|
90-day follow-up after surgery
|
|
NDI (neck disability index) score
Lasso di tempo: Baseline
|
NDI score, 0-100%, higher means worse outcomes
|
Baseline
|
|
NDI (neck disability index) score
Lasso di tempo: 90-day follow-up after surgery
|
NDI score, 0-100%, higher means worse outcomes
|
90-day follow-up after surgery
|
|
symptoms of neck and shoulder
Lasso di tempo: Baseline
|
The presence or absence of neck and shoulder pain symptoms
|
Baseline
|
|
symptoms of neck and shoulder
Lasso di tempo: 90-day follow-up after surgery
|
The presence or absence of neck and shoulder pain symptoms
|
90-day follow-up after surgery
|
|
symptoms of neck and shoulder
Lasso di tempo: Baseline
|
The presence or absence of neck and shoulder stiffness symptoms
|
Baseline
|
|
symptoms of neck and shoulder
Lasso di tempo: 90-day follow-up after surgery
|
The presence or absence of neck and shoulder stiffness symptoms
|
90-day follow-up after surgery
|
|
neurological function
Lasso di tempo: Baseline
|
the Japanese Orthopaedic Society Association (JOA) score, 0-17 points, lower means worse outcomes
|
Baseline
|
|
neurological function
Lasso di tempo: 90-day follow-up after surgery
|
the Japanese Orthopaedic Society Association (JOA) score, 0-17 points, lower means worse outcomes
|
90-day follow-up after surgery
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- LM2019195
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .