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A Greek-designed ERAS Protocol in Elective Craniotomy (ERAS)

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ClinicalTrials.gov Identifier: NCT05962684
Recruitment Status : Recruiting
First Posted : July 27, 2023
Last Update Posted : July 27, 2023
Sponsor:
Information provided by (Responsible Party):
Elena Arnaoutoglou, University of Thessaly

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

Condition or disease Intervention/treatment
ERAS Craniotomy Other: ERAS

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 Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Greek-designed Enhanced Recovery After Surgery (ERAS) Protocol in Elective Cranial Neurosurgical Procedures: An Observational Study
Actual Study Start Date : May 31, 2023
Estimated Primary Completion Date : May 31, 2024
Estimated Study Completion Date : July 30, 2024
Groups and Cohorts
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Group/Cohort Intervention/treatment
ERAS Other: ERAS
Implementation of ERAS protocol in elective craniotomy patients


Outcome Measures
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Primary Outcome Measures :
  1. Hospital Length of Stay [ Time Frame: up to 7 days ]
    The days the patient stays in hospital


Secondary Outcome Measures :
  1. Pain score [ Time Frame: Postoperative Day 1 to discharge, an average of 7 days ]
    Pain intensity as measured by Visual Analogue Scale (VAS)

  2. 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

  3. Patient's satisfaction [ Time Frame: 1 day at discharge and 1 month postoperatively ]
    Patient's satisfaction as measured by a Likert Scale

  4. 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)

  5. Personality Index [ Time Frame: Preoperatively, second postoperative day and one month postoperatively ]
    Personality Index as measured by TIPI


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients undergoing elective craniotomy
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05962684


Contacts
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Contact: Eleni Arnaoutoglou, MD, PhD +306974301352 earnaout@gmail.com
Contact: Metaxia Bareka, MD, PhD +306947845083 barekametaxia@hotmail.com

Locations
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Greece
University of Thessaly Recruiting
Larissa, Greece, 41110
Contact: Eleni Arnaoutoglou, MD, PhD    +306974301352    earnaout@gmail.com   
Contact: Metaxia Bareka, MD, PhD    +306947845083    barekametaxia@hotmail.com   
Principal Investigator: Konstantinos Fountas, MD, PhD         
Sub-Investigator: Metaxia Bareka, MD, PhD         
Principal Investigator: Eleni Arnaoutoglou, MD, PhD         
Sub-Investigator: Alexandros Brotis, MD, PhD         
Sub-Investigator: Mary Solou, MD, MSc         
Sponsors and Collaborators
University of Thessaly
Investigators
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Study Director: Eleni Arnaoutolglou, MD, PhD University of Thessaly
Study Chair: Konstantinos Fountas, MD, PhD University of Thessaly
More Information
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Publications of Results:

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Responsible Party: Elena Arnaoutoglou, Professor in Anesthesiology, University of Thessaly
ClinicalTrials.gov Identifier: NCT05962684    
Other Study ID Numbers: ERAS Craniotomy
First Posted: July 27, 2023    Key Record Dates
Last Update Posted: July 27, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elena Arnaoutoglou, University of Thessaly:
ERAS
Craniotomy
Perioperative management