ERAS on Cervical Surgery
Evaluation of the Effect of Enhanced Recovery After Surgery for Cervical Surgery
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
-
-
Beijing
-
Beijing, Beijing, China, 100083
- Peking University Third Hospital
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
ERAS Group
Patients were treated by enhanced recovery after surgery
|
Das ERAS-Management umfasst 3 Teile: (1) Präoperative Analgesie und Beurteilung der Atemwege.
(2) Der Schutz und die Rekonstruktion des Muskel-Band-Komplexes während der Operation, die sichere Intubation und die lokale Infiltrationsanästhesie während der Operation.
(3) Halsbandfreie, multimodale Analgesie, Atemwegsmanagement und frühe Genesung nach der Operation.
|
|
Control Group
Patients were not treated by enhanced recovery after surgery
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
the ability of daily living
Zeitfenster: Baseline
|
The medical history related to the ability of daily living
|
Baseline
|
|
the ability of daily living
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Admission to discharge, an average of 3 days
|
the cost of hospitalization
|
Admission to discharge, an average of 3 days
|
|
the rehospitalization rate
Zeitfenster: 90-day follow-up after surgery
|
the rehospitalization rate of 90 days
|
90-day follow-up after surgery
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
VAS (visual analog scale ) score
Zeitfenster: Baseline
|
VAS score of neck and shoulder pain, 0-100 points, higher means worse outcomes
|
Baseline
|
|
VAS (visual analog scale ) score
Zeitfenster: 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
Zeitfenster: Baseline
|
NDI score, 0-100%, higher means worse outcomes
|
Baseline
|
|
NDI (neck disability index) score
Zeitfenster: 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
Zeitfenster: Baseline
|
The presence or absence of neck and shoulder pain symptoms
|
Baseline
|
|
symptoms of neck and shoulder
Zeitfenster: 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
Zeitfenster: Baseline
|
The presence or absence of neck and shoulder stiffness symptoms
|
Baseline
|
|
symptoms of neck and shoulder
Zeitfenster: 90-day follow-up after surgery
|
The presence or absence of neck and shoulder stiffness symptoms
|
90-day follow-up after surgery
|
|
neurological function
Zeitfenster: Baseline
|
the Japanese Orthopaedic Society Association (JOA) score, 0-17 points, lower means worse outcomes
|
Baseline
|
|
neurological function
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- LM2019195
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .