A Greek-designed ERAS Protocol in Elective Craniotomy (ERAS)
July 26, 2023 updated by: Elena Arnaoutoglou, University of Thessaly
A Greek-designed Enhanced Recovery After Surgery (ERAS) Protocol in Elective Cranial Neurosurgical Procedures: An Observational Study
The implementation of ERAS protocol in elective cranial neurosurgical cases in a tertiary hospital.
Study Overview
Detailed 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
Study Type
Observational
Enrollment (Estimated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Eleni Arnaoutoglou, MD, PhD
- Phone Number: +306974301352
- Email: earnaout@gmail.com
Study Contact Backup
- Name: Metaxia Bareka, MD, PhD
- Phone Number: +306947845083
- Email: barekametaxia@hotmail.com
Study Locations
-
-
-
Larissa, Greece, 41110
- Recruiting
- University of Thessaly
-
Sub-Investigator:
- Alexandros Brotis, MD, PhD
-
Contact:
- Eleni Arnaoutoglou, MD, PhD
- Phone Number: +306974301352
- Email: earnaout@gmail.com
-
Principal Investigator:
- Eleni Arnaoutoglou, MD, PhD
-
Contact:
- Metaxia Bareka, MD, PhD
- Phone Number: +306947845083
- Email: barekametaxia@hotmail.com
-
Principal Investigator:
- Konstantinos Fountas, MD, PhD
-
Sub-Investigator:
- Metaxia Bareka, MD, PhD
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Sub-Investigator:
- Mary Solou, MD, MSc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Adult patients undergoing elective craniotomy
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
ERAS
|
Implementation of ERAS protocol in elective craniotomy patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital Length of Stay
Time Frame: up to 7 days
|
The days the patient stays in hospital
|
up to 7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain score
Time Frame: Postoperative Day 1 to discharge, an average of 7 days
|
Pain intensity as measured by Visual Analogue Scale (VAS)
|
Postoperative Day 1 to discharge, an average of 7 days
|
|
Mental status
Time Frame: 1 day at discharge
|
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
|
|
Patient's satisfaction
Time Frame: 1 day at discharge and 1 month postoperatively
|
Patient's satisfaction as measured by a Likert Scale
|
1 day at discharge and 1 month postoperatively
|
|
Anxiety and Depression
Time Frame: Preoperatively, second postoperative day and one month postoperatively
|
Anxiety and Depression level as measured by Hospital Anxiety and Depression Scale (HADS)
|
Preoperatively, second postoperative day and one month postoperatively
|
|
Personality Index
Time Frame: Preoperatively, second postoperative day and one month postoperatively
|
Personality Index as measured by TIPI
|
Preoperatively, second postoperative day and one month postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Eleni Arnaoutolglou, MD, PhD, University of Thessaly
- Study Chair: Konstantinos Fountas, MD, PhD, University of Thessaly
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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. Front Oncol. 2022 May 24;12:860257. doi: 10.3389/fonc.2022.860257. eCollection 2022.
- 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.
- 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 recovery after surgery protocol for elective craniotomy: a prospective randomized controlled trial. J Neurosurg. 2018 Jun 1:1-12. doi: 10.3171/2018.1.JNS171552. Online ahead of print.
- 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: 10.3171/2020.10.JNS203160.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 31, 2023
Primary Completion (Estimated)
May 31, 2024
Study Completion (Estimated)
July 30, 2024
Study Registration Dates
First Submitted
July 12, 2023
First Submitted That Met QC Criteria
July 26, 2023
First Posted (Actual)
July 27, 2023
Study Record Updates
Last Update Posted (Actual)
July 27, 2023
Last Update Submitted That Met QC Criteria
July 26, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ERAS Craniotomy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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