Clinical trial NCT05962684: A Greek-designed ERAS Protocol in Elective Craniotomy
Official title: A Greek-designed Enhanced Recovery After Surgery (ERAS) Protocol in Elective Cranial Neurosurgical Procedures: An Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ERAS
Craniotomy
Keywords: ERAS
Craniotomy
Perioperative management
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients undergoing elective craniotomy

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Hospital Length of Stay
timeFrame: up to 7 days
Secondary outcomes:
measure: Pain score
timeFrame: Postoperative Day 1 to discharge, an average of 7 days
measure: Mental status
timeFrame: 1 day at discharge
measure: Patient's satisfaction
timeFrame: 1 day at discharge and 1 month postoperatively
measure: Anxiety and Depression
timeFrame: Preoperatively, second postoperative day and one month postoperatively
measure: Personality Index
timeFrame: Preoperatively, second postoperative day and one month postoperatively
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: University of Thessaly
Study officials:
affiliation: University of Thessaly
name: Eleni Arnaoutolglou, MD, PhD
role: STUDY_DIRECTOR
affiliation: University of Thessaly
name: Konstantinos Fountas, MD, PhD
role: STUDY_CHAIR
References:
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.
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. Front Oncol. 2022 May 24;12:860257. doi: 10.3389/fonc.2022.860257. eCollection 2022.
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.
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 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.
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: 10.3171/2020.10.JNS203160. Print 2021 Dec 1.
citation: 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.