Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

ERAS on Cervical Surgery

7. juli 2021 opdateret af: 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

Studieoversigt

Status

Afsluttet

Betingelser

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

Observationel

Tilmelding (Faktiske)

2000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. september 2019

Primær færdiggørelse (Faktiske)

20. september 2019

Studieafslutning (Faktiske)

30. september 2019

Datoer for studieregistrering

Først indsendt

1. juli 2021

Først indsendt, der opfyldte QC-kriterier

7. juli 2021

Først opslået (Faktiske)

8. juli 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juli 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juli 2021

Sidst verificeret

1. juli 2021

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner