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ERAS on Cervical Surgery

7. juli 2021 oppdatert av: Peking University Third Hospital

Evaluation of the Effect of Enhanced Recovery After Surgery for Cervical Surgery

This study is to evaluate the application effect of the concept of accelerated rehabilitation surgery in the perioperative period of patients with cervical spondylosis through a retrospective cohort study

Studieoversikt

Status

Fullført

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

Observasjonsmessig

Registrering (Faktiske)

2000

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Beijing
      • Beijing, Beijing, Kina, 100083
        • Peking University Third Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

the patients who underwent cervical spine surgery

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

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

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. september 2019

Primær fullføring (Faktiske)

20. september 2019

Studiet fullført (Faktiske)

30. september 2019

Datoer for studieregistrering

Først innsendt

1. juli 2021

Først innsendt som oppfylte QC-kriteriene

7. juli 2021

Først lagt ut (Faktiske)

8. juli 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. juli 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. juli 2021

Sist bekreftet

1. juli 2021

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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