- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04955496
ERAS on Cervical Surgery
Evaluation of the Effect of Enhanced Recovery After Surgery for Cervical Surgery
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Beijing
-
Beijing, Beijing, Kina, 100083
- Peking University Third Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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 undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
ERAS Group
Patients were treated by enhanced recovery after surgery
|
ERAS-styring omfatter 3 dele: (1) Præoperativ analgesi og luftvejsevaluering.
(2) Beskyttelsen og rekonstruktionen af det muskulo-ligamentøse kompleks under operationen, den sikre intubation og den lokale infiltrationsanæstesi under operationen.
(3) Halsbåndsfri, multimodal analgesi, luftvejsbehandling og tidlig genopretning efter operation.
|
|
Control Group
Patients were not treated by enhanced recovery after surgery
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- LM2019195
Plan for individuelle deltagerdata (IPD)
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