A Greek-designed ERAS Protocol in Elective Craniotomy

Recruiting

• Conditions: ERAS; Craniotomy
• Interventions: Other: ERAS

• Registration Number: NCT05962684
• Lead Sponsor: University of Thessaly

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

Study Timeline

• Study Start: 2023-05-31
• Status Verified: 2023-07
• Study First Submitted: 2023-07-12
• Study First Submitted QC: 2023-07-26
• Last Update Submitted: 2023-07-26
• Study First Posted: 2023-07-27
• Last Update Posted: 2023-07-27
• Primary Completion: 2024-05-31
• Study Completion: 2024-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ERAS	ERAS	-

Primary Outcome Measures

Name	Time	Method
Hospital Length of Stay	up to 7 days	The days the patient stays in hospital

Secondary Outcome Measures

Name	Time	Method
Mental status	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
Anxiety and Depression	Preoperatively, second postoperative day and one month postoperatively	Anxiety and Depression level as measured by Hospital Anxiety and Depression Scale (HADS)
Pain score	Postoperative Day 1 to discharge, an average of 7 days	Pain intensity as measured by Visual Analogue Scale (VAS)
Personality Index	Preoperatively, second postoperative day and one month postoperatively	Personality Index as measured by TIPI
Patient's satisfaction	1 day at discharge and 1 month postoperatively	Patient's satisfaction as measured by a Likert Scale

Trial Locations

Locations (1)

University of Thessaly; 🇬🇷 Larissa, Greece