- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT04955496
ERAS on Cervical Surgery
Evaluation of the Effect of Enhanced Recovery After Surgery for Cervical Surgery
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
Beijing
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Beijing, Beijing, China, 100083
- Peking University Third Hospital
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
ERAS Group
Patients were treated by enhanced recovery after surgery
|
O gerenciamento do ERAS inclui 3 partes: (1) Analgesia pré-operatória e avaliação das vias aéreas.
(2) A proteção e reconstrução do complexo músculo-ligamentar durante a cirurgia, a intubação segura e a infiltração anestésica local durante a cirurgia.
(3) Analgesia multimodal sem colar, manejo das vias aéreas e recuperação precoce após a cirurgia.
|
|
Control Group
Patients were not treated by enhanced recovery after surgery
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
the ability of daily living
Prazo: Baseline
|
The medical history related to the ability of daily living
|
Baseline
|
|
the ability of daily living
Prazo: 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
Prazo: Admission to discharge, an average of 3 days
|
the length of hospital stay
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Admission to discharge, an average of 3 days
|
|
the cost of hospitalization
Prazo: Admission to discharge, an average of 3 days
|
the cost of hospitalization
|
Admission to discharge, an average of 3 days
|
|
the rehospitalization rate
Prazo: 90-day follow-up after surgery
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the rehospitalization rate of 90 days
|
90-day follow-up after surgery
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
VAS (visual analog scale ) score
Prazo: Baseline
|
VAS score of neck and shoulder pain, 0-100 points, higher means worse outcomes
|
Baseline
|
|
VAS (visual analog scale ) score
Prazo: 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
Prazo: Baseline
|
NDI score, 0-100%, higher means worse outcomes
|
Baseline
|
|
NDI (neck disability index) score
Prazo: 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
Prazo: Baseline
|
The presence or absence of neck and shoulder pain symptoms
|
Baseline
|
|
symptoms of neck and shoulder
Prazo: 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
Prazo: Baseline
|
The presence or absence of neck and shoulder stiffness symptoms
|
Baseline
|
|
symptoms of neck and shoulder
Prazo: 90-day follow-up after surgery
|
The presence or absence of neck and shoulder stiffness symptoms
|
90-day follow-up after surgery
|
|
neurological function
Prazo: Baseline
|
the Japanese Orthopaedic Society Association (JOA) score, 0-17 points, lower means worse outcomes
|
Baseline
|
|
neurological function
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- LM2019195
Plano para dados de participantes individuais (IPD)
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