NCT05962684

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 31, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 12, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

1 year

First QC Date

July 12, 2023

Last Update Submit

July 26, 2023

Conditions

ERASCraniotomy

Keywords

ERASCraniotomyPerioperative management

Outcome Measures

Primary Outcomes (1)

  • Hospital Length of Stay

    The days the patient stays in hospital

    up to 7 days

Secondary Outcomes (5)

  • Pain score

    Postoperative Day 1 to discharge, an average of 7 days

  • Mental status

    1 day at discharge

  • Patient's satisfaction

    1 day at discharge and 1 month postoperatively

  • Anxiety and Depression

    Preoperatively, second postoperative day and one month postoperatively

  • Personality Index

    Preoperatively, second postoperative day and one month postoperatively

Study Arms (1)

ERAS

Other: ERAS

Interventions

ERASOTHER

Implementation of ERAS protocol in elective craniotomy patients

ERAS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients undergoing elective craniotomy

You may qualify if:

  • Medically suitable for elective craniotomy
  • ASA-PS I-III

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Thessaly

Larissa, 41110, Greece

RECRUITING

Related Publications (6)

  • 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.

    PMID: 34739947RESULT

  • 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.

    PMID: 35686112RESULT

  • 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.

    PMID: 33740911RESULT

  • 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 22;130(5):1680-1691. doi: 10.3171/2018.1.JNS171552. Print 2019 May 1.

    PMID: 29932379RESULT

  • 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. Print 2021 Dec 1.

    PMID: 33962374RESULT

  • 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.

    PMID: 34509236RESULT

Study Officials

  • Eleni Arnaoutolglou, MD, PhD

    University of Thessaly

    STUDY DIRECTOR

  • Konstantinos Fountas, MD, PhD

    University of Thessaly

    STUDY CHAIR

Central Study Contacts

Eleni Arnaoutoglou, MD, PhD

CONTACT

+306974301352earnaout@gmail.com

Metaxia Bareka, MD, PhD

CONTACT

+306947845083barekametaxia@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Anesthesiology

Study Record Dates

First Submitted

July 12, 2023

First Posted

July 27, 2023

Study Start

May 31, 2023

Primary Completion

May 31, 2024

Study Completion

July 30, 2024

Last Updated

July 27, 2023

Record last verified: 2023-07

Locations

GR(1)