- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04955496
ERAS on Cervical Surgery
Evaluation of the Effect of Enhanced Recovery After Surgery for Cervical Surgery
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Beijing
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Beijing, Beijing, 중국, 100083
- Peking University Third Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
ERAS Group
Patients were treated by enhanced recovery after surgery
|
ERAS 관리에는 3가지 부분이 포함됩니다. (1) 수술 전 진통 및 기도 평가.
(2) 수술 중 근인대 복합체의 보호 및 재건, 안전한 삽관 및 수술 중 국소 침윤 마취.
(3) 칼라가 없는 다중 모드 진통, 기도 관리 및 수술 후 조기 회복.
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Control Group
Patients were not treated by enhanced recovery after surgery
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
the ability of daily living
기간: Baseline
|
The medical history related to the ability of daily living
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Baseline
|
the ability of daily living
기간: 90-day follow-up after surgery
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The medical history related to the ability of daily living
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90-day follow-up after surgery
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the length of hospital stay
기간: Admission to discharge, an average of 3 days
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the length of hospital stay
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Admission to discharge, an average of 3 days
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the cost of hospitalization
기간: Admission to discharge, an average of 3 days
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the cost of hospitalization
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Admission to discharge, an average of 3 days
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the rehospitalization rate
기간: 90-day follow-up after surgery
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the rehospitalization rate of 90 days
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90-day follow-up after surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
VAS (visual analog scale ) score
기간: Baseline
|
VAS score of neck and shoulder pain, 0-100 points, higher means worse outcomes
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Baseline
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VAS (visual analog scale ) score
기간: 90-day follow-up after surgery
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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
기간: Baseline
|
NDI score, 0-100%, higher means worse outcomes
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Baseline
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NDI (neck disability index) score
기간: 90-day follow-up after surgery
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NDI score, 0-100%, higher means worse outcomes
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90-day follow-up after surgery
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symptoms of neck and shoulder
기간: Baseline
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The presence or absence of neck and shoulder pain symptoms
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Baseline
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symptoms of neck and shoulder
기간: 90-day follow-up after surgery
|
The presence or absence of neck and shoulder pain symptoms
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90-day follow-up after surgery
|
symptoms of neck and shoulder
기간: Baseline
|
The presence or absence of neck and shoulder stiffness symptoms
|
Baseline
|
symptoms of neck and shoulder
기간: 90-day follow-up after surgery
|
The presence or absence of neck and shoulder stiffness symptoms
|
90-day follow-up after surgery
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neurological function
기간: Baseline
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the Japanese Orthopaedic Society Association (JOA) score, 0-17 points, lower means worse outcomes
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Baseline
|
neurological function
기간: 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
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- LM2019195
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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