- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04955496
ERAS on Cervical Surgery
Evaluation of the Effect of Enhanced Recovery After Surgery for Cervical Surgery
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Beijing
-
Beijing, Beijing, Kina, 100083
- Peking University Third Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
ERAS Group
Patients were treated by enhanced recovery after surgery
|
ERAS-behandling inkluderer 3 deler: (1) Preoperativ analgesi og luftveisevaluering.
(2) Beskyttelse og rekonstruksjon av muskel-ligamentkomplekset under operasjonen, sikker intubasjon og lokal infiltrasjonsanestesi under operasjonen.
(3) Kragefri, multimodal analgesi, luftveisbehandling og tidlig restitusjon etter operasjon.
|
|
Control Group
Patients were not treated by enhanced recovery after surgery
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
the ability of daily living
Tidsramme: Baseline
|
The medical history related to the ability of daily living
|
Baseline
|
|
the ability of daily living
Tidsramme: 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
Tidsramme: 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
Tidsramme: Admission to discharge, an average of 3 days
|
the cost of hospitalization
|
Admission to discharge, an average of 3 days
|
|
the rehospitalization rate
Tidsramme: 90-day follow-up after surgery
|
the rehospitalization rate of 90 days
|
90-day follow-up after surgery
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
VAS (visual analog scale ) score
Tidsramme: Baseline
|
VAS score of neck and shoulder pain, 0-100 points, higher means worse outcomes
|
Baseline
|
|
VAS (visual analog scale ) score
Tidsramme: 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
Tidsramme: Baseline
|
NDI score, 0-100%, higher means worse outcomes
|
Baseline
|
|
NDI (neck disability index) score
Tidsramme: 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
Tidsramme: Baseline
|
The presence or absence of neck and shoulder pain symptoms
|
Baseline
|
|
symptoms of neck and shoulder
Tidsramme: 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
Tidsramme: Baseline
|
The presence or absence of neck and shoulder stiffness symptoms
|
Baseline
|
|
symptoms of neck and shoulder
Tidsramme: 90-day follow-up after surgery
|
The presence or absence of neck and shoulder stiffness symptoms
|
90-day follow-up after surgery
|
|
neurological function
Tidsramme: Baseline
|
the Japanese Orthopaedic Society Association (JOA) score, 0-17 points, lower means worse outcomes
|
Baseline
|
|
neurological function
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- LM2019195
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