A Greek-designed ERAS Protocol in Elective Craniotomy

ERAS Clinical Trial

— ERAS  

Official title:

A Greek-designed Enhanced Recovery After Surgery (ERAS) Protocol in Elective Cranial Neurosurgical Procedures: An Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05962684
• Other study ID #: ERAS Craniotomy
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Craniotomy
• ERAS

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