ERASERASNCT05962684
A Greek-designed ERAS Protocol in Elective Craniotomy
An observational study of ERAS and Craniotomy, run by University of Thessaly at 1 site in Greece.
Trial summary
The implementation of ERAS protocol in elective cranial neurosurgical cases in a tertiary hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ERAS, Craniotomy
- What is being tested?
- ERAS
- How many people
- 30 participants
- Where
- 1 siteGreece
- Study dates
- 31 May 2023to 30 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing elective craniotomy
Who may be able to join
- Medically suitable for elective craniotomy
- ASA-PS I-III
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
University of Thessaly
Larissa, 41110
Eleni Arnaoutoglou, MD, PhD, +306974301352, earnaout@gmail.com
Metaxia Bareka, MD, PhD, +306947845083, barekametaxia@hotmail.com
About this study
Official title: 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.
Read the 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
- Conditions
- ERAS, Craniotomy
- Being tested
- ERAS
- Keywords
- ERAS, Craniotomy, Perioperative management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERASOther
Implementation of ERAS protocol in elective craniotomy patients
| Study group | Role | What they receive |
|---|---|---|
| ERAS | Not described Receives: Other: ERAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Length of Stay
The days the patient stays in hospital
Measured: up to 7 days
Secondary outcomes (5)
Pain score
Pain intensity as measured by Visual Analogue Scale (VAS)
Measured: Postoperative Day 1 to discharge, an average of 7 days
Mental status
Mental status as measured by Glasgow Coma Scale (GCS) Minimum value : 3 Maximum value : 15 Higher scores mean a better outcome
Measured: 1 day at discharge
Patient's satisfaction
Patient's satisfaction as measured by a Likert Scale
Measured: 1 day at discharge and 1 month postoperatively
Anxiety and Depression
Anxiety and Depression level as measured by Hospital Anxiety and Depression Scale (HADS)
Measured: Preoperatively, second postoperative day and one month postoperatively
Personality Index
Personality Index as measured by TIPI
Measured: Preoperatively, second postoperative day and one month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start31 May 2023
- Primary completion31 May 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ERASStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Arnaoutoglou, University of Thessaly
- Investigators
- Eleni Arnaoutolglou, MD, PhD, Study director, University of ThessalyKonstantinos Fountas, MD, PhD, Study chair, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962684
- Sponsor's protocol ID
- ERAS Craniotomy
- Acronym
- ERAS
- Status last verified
- Jul 2023
- First submitted
- 12 Jul 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 34739947Wang 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.
PubMed 35686112Elayat 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.
PubMed 33740911Wang 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.
PubMed 29932379Stumpo 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.
PubMed 33962374Agarwal 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.
PubMed 34509236
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Greek-designed Enhanced Recovery After Surgery (ERAS) Protocol in Elective Cranial Neurosurgical Procedures: An Observational Study
- ClinicalTrials.gov ID
- NCT05962684
- Acronym / sponsor ID
- ERAS / ERAS Craniotomy
- Conditions
- ERAS, Craniotomy
- Keywords
- ERAS, Craniotomy, Perioperative management
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 31 May 2023 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ERAS | – | Other: ERAS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective craniotomy
Key inclusion criteria (2 listed)
- Medically suitable for elective craniotomy
- ASA-PS I-III
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERASImplementation of ERAS protocol in elective craniotomy patients | Other | ERAS |
Primary outcome
Hospital Length of Stay
Time frame: up to 7 days
The days the patient stays in hospital
5 secondary outcomes
Pain score
Time frame: Postoperative Day 1 to discharge, an average of 7 days
Mental status
Time frame: 1 day at discharge
Patient's satisfaction
Time frame: 1 day at discharge and 1 month postoperatively
Anxiety and Depression
Time frame: Preoperatively, second postoperative day and one month postoperatively
Personality Index
Time frame: Preoperatively, second postoperative day and one month postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Results publication: PubMed 34739947Wang 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.
- Results publication: PubMed 35686112Wang 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.
- Results publication: PubMed 33740911Elayat 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.
- Results publication: PubMed 29932379Wang 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.
- Results publication: PubMed 33962374Stumpo 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.
- Results publication: PubMed 34509236Agarwal 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eleni Arnaoutolglou, MD, PhD study director
University of Thessaly
Konstantinos Fountas, MD, PhD study chair
University of Thessaly
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ERAS and Craniotomy, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eleni Arnaoutoglou, MD, PhD (+306974301352, earnaout@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Length of Stay (time frame: up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05962684, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.