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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05962684
Other study ID # ERAS Craniotomy
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 31, 2023
Est. completion date July 30, 2024

Study information

Verified date July 2023
Source University of Thessaly
Contact Eleni Arnaoutoglou, MD, PhD
Phone +306974301352
Email earnaout@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The implementation of ERAS protocol in elective cranial neurosurgical cases in a tertiary hospital.


Description:

In this study, the investigators have integrated the most current data from literature aiming to investigate the effectiveness of a contemporary ERAS protocol for elective cranial neurosurgical cases in a tertiary hospital. The hypothesis is that the implementation of such protocol will shorten the postoperative length of stay, minimize the complication rates, and improve the overall clinical status of patients undergoing elective craniotomy compared to the standard perioperative care


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date July 30, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Medically suitable for elective craniotomy - ASA-PS I-III Exclusion Criteria: - traumatic lesions - pathology requiring emergent surgery - preoperative loss of consciousness - severe co-morbidities that may affect postoperative recovery (e.g. paralysis, autoimmune diseases, myocardial or severe infarction, heart, liver or lung malfunction, severe mental illness etc.) - recurrent tumor

Study Design


Related Conditions & MeSH terms


Intervention

Other:
ERAS
Implementation of ERAS protocol in elective craniotomy patients

Locations

Country Name City State
Greece University of Thessaly Larissa

Sponsors (1)

Lead Sponsor Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

References & Publications (6)

Agarwal P, Frid I, Singer J, Zalatimo O, Schirmer CM, Kimmell KT, Agarwal N. Neurosurgery perception of Enhanced Recovery After Surgery (ERAS) protocols. J Clin Neurosci. 2021 Oct;92:110-114. doi: 10.1016/j.jocn.2021.07.044. Epub 2021 Aug 7. — View Citation

Elayat A, Jena SS, Nayak S, Sahu RN, Tripathy S. "Enhanced recovery after surgery - ERAS in elective craniotomies-a non-randomized controlled trial". BMC Neurol. 2021 Mar 19;21(1):127. doi: 10.1186/s12883-021-02150-7. — View Citation

Stumpo V, Staartjes VE, Quddusi A, Corniola MV, Tessitore E, Schroder ML, Anderer EG, Stienen MN, Serra C, Regli L. Enhanced Recovery After Surgery strategies for elective craniotomy: a systematic review. J Neurosurg. 2021 May 7;135(6):1857-1881. doi: 10. — View Citation

Wang L, Cai H, Wang Y, Liu J, Chen T, Liu J, Huang J, Guo Q, Zou W. Enhanced recovery after elective craniotomy: A randomized controlled trial. J Clin Anesth. 2022 Feb;76:110575. doi: 10.1016/j.jclinane.2021.110575. Epub 2021 Nov 2. — View Citation

Wang Y, Liu B, Zhao T, Zhao B, Yu D, Jiang X, Ye L, Zhao L, Lv W, Zhang Y, Zheng T, Xue Y, Chen L, Sankey E, Chen L, Wu Y, Li M, Ma L, Li Z, Li R, Li J, Yan J, Wang S, Zhao H, Sun X, Gao G, Qu Y, He S. Safety and efficacy of a novel neurosurgical enhanced — View Citation

Wang Y, Xue YF, Zhao BF, Guo SC, Ji PG, Liu JH, Wang N, Chen F, Zhai YL, Wang Y, Xue YR, Gao GD, Qu Y, Wang L. Real-World Implementation of Neurosurgical Enhanced Recovery After Surgery Protocol for Gliomas in Patients Undergoing Elective Craniotomy. Fron — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Hospital Length of Stay The days the patient stays in hospital up to 7 days
Secondary Pain score Pain intensity as measured by Visual Analogue Scale (VAS) Postoperative Day 1 to discharge, an average of 7 days
Secondary Mental status Mental status as measured by Glasgow Coma Scale (GCS) Minimum value : 3 Maximum value : 15 Higher scores mean a better outcome 1 day at discharge
Secondary Patient's satisfaction Patient's satisfaction as measured by a Likert Scale 1 day at discharge and 1 month postoperatively
Secondary Anxiety and Depression Anxiety and Depression level as measured by Hospital Anxiety and Depression Scale (HADS) Preoperatively, second postoperative day and one month postoperatively
Secondary Personality Index Personality Index as measured by TIPI Preoperatively, second postoperative day and one month postoperatively
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