Postoperative PainIPAST-CRANIONCT05112575
Evaluation of Patient Stress Level Caused by Radiological Investigations in Early Postoperative Phase After Craniotomy
An observational study of Postoperative Pain and Postoperative Nausea, run by University of Zurich at 1 site in Switzerland.
Trial summary
Postoperative imaging after neurosurgical intervention is usually performed in the first 72 hours after surgery. Postoperative radiological examinations in the first 72 hours provide accurate assessment of postoperative resection status. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain, Postoperative Nausea
- What is being tested?
- Postoperative imaging with magnetic resonance imaging or computed tomography
- Type of treatment
- Surgery or procedure
- How many people
- 152 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Sep 2020to 1 Feb 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Data will be collected from patients between 18 and 80 years old who receive MRI or CT follow-up after craniotomy for resection of a space occupying lesion (benign or malignant) or for any vascular procedure at the Department of Neurosurgery at the University Hospital Zurich
Who may be able to join
- Written consent of the patient
- Age between 18 and 80 years
- Planned for supra- or infratentorial (partial) resection of space occupying lesion (benign or malignant) or vascular neurosurgical procedure (clipping of an aneurysm, resection of an arteriovenous malformation, resection of cavernoma)
- Patients planned for MRI or CT follow-up within 72 hours after surgery
Who cannot join
- No informed consent
- Operation using only one burr hole (e.g. biopsy)
- Not able to fill out the questionnaires due to cognitive impairment or aphasia
- Not understanding German or English language
- Contraindication for MRI examination
- No postoperative MRI or CT examination planned within 72 hours after surgery
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Neurosurgery, University Hospital Zurich
Zurich, 8091
About this study
Official title: Evaluation of Patient Stress Level Caused by Radiological Investigations in Early Postoperative Phase After Craniotomy (IPAST-CRANIO): Protocol of a Swiss Prospective Cohort Study
Postoperative imaging after neurosurgical intervention is usually performed in the first 72 hours after surgery. Postoperative radiological examinations in the first 72 hours provide accurate assessment of postoperative resection status. On the other side is frequently reported by patients that the earlier postoperative examinations after craniotomy for tumor and vascular procedures are associated with distress, exertion, nausea, and pain. Therefore, psychological and physical stress on the patient could be a potential disadvantage of earlier (up to 36 hours postoperatively) follow-up. The goal of this study is to evaluate and determine the optimal time frame for postoperative imaging with MRI and CT in terms of medical and neuroradiological implications and patient's subjective stress.
The primary endpoint of the study is the extent of subjective distress due to postoperative MRI and CT monitoring in relation to the time interval after surgery Data will be prospectively collected from all patients aged 18 to 80 years who receive postoperative MRI or CT follow-up after craniotomy for resection of a cerebral tumor (benign and malignant) or vascular surgery.
This study determines, whether a timing of postoperative imaging can improve patient satisfaction and reduce pain, stress and discomfort caused by postoperative imaging. The outcome corresponds to the value-based medicine approach of modern patient-centred medicine. Results will be published in peer-reviewed journals and electronic patient data will be safely stored for 15 years.
Read the detailed description
Background and rationale Magnetic resonance imaging (MRI) after neurosurgical resection of a cerebral tumor is usually performed in the first 72 hours after surgery. 1-4 Accurate assessment of early postoperative resection status in brain tumors is mandatory for further treatment planning, e.g., delineation of the radiation field in radiotherapy, or reoperation for significant residual tumor. 5 Various MRI-sequences provide information on tumor size and location, as well as additional insight into secondary phenomena such as edema, hemorrhage, infarct, necrosis, and signs of increased intracranial pressure. 1, 3, 5, 6 The 72 hours' time window is crucial for accurate assessment of resection status and is additionally used for quality control of the neurosurgical procedure. 7 Postoperative MRI later than 72 hours after surgery can lead to false positive contrast enhancement due to absorption of contrast in the surgical area which can complicate the assessment of resection status. 1, 6 Postsurgical repair mechanisms at the resection site that result from hypervascularization and disruption of blood-brain barrier are probably responsible for this delayed enhancement. 7 The potential advantages of early imaging (within 36 hours after surgery) are better radiological assessment of the surgical site and earlier diagnosis of postoperative complications, such as infarcts, postoperative bleeding or edema. This may help in improving the postoperative management of patients with complications. Moreover, earlier information about the outcome of surgery could also lead to psychological relief for patients in the early postoperative period. Disadvantages of early postoperative examinations after craniotomy are frequently reported by patients and include distress, exertion, nausea, and pain during and after the examination. As such, psychological and physical patient stress could be a potential disadvantage of early (within 36 hours after surgery) MRI examination. An alternative image modality is Computed Tomography (CT), which may be less stressful for the patients because it takes only 5 to 10 minutes to complete the scan and the patients do not have to lie in small claustrophobic space compared to MRI. However, with this modality the postoperative resection status cannot reliably be assessed. To the authors knowledge, no previous literature has been published which addressed the stress factors during postoperative imaging. To authors opinion, a more patient-centered view regarding postoperative MRI investigation needs more clarification, so the authors want to investigate the intensity of patient stress after postoperative imaging at different intervals from surgery. With optimization of the time window of the MRI examination, the authors want to improve the psychological and physical patient stress, which may have a positive influence on early recovery. Additionally, establishing an optimal time window for postoperative MRI imaging will help in scheduling the examination before the elective surgical treatment. This will have a positive impact on preparing patients, radiology employees, nurses and physicians for a smooth and easy transport to and from the MRI examination.
Objectives The goal of this study is to assess whether early imaging with MRI (within 36 hours) after craniotomy is different regarding patient stress, than delayed imaging (between 36 and 72 hours). Secondly, the authors want to assess whether there is a difference in patient stress level between postoperative MRI and CT within 72 hours postoperatively.
The authors hypothesize that delayed imaging with MRI after craniotomy is more comfortable for patients without negative implication of radiological assessment, than imaging within 36 hours. Secondly, the authors hypothesize that postoperative MRI is more stressful for patients than CT.
Trial design The IPAST-CRANIO study (Evaluation of patient STress level caused by radiological Investigations in early Postoperative phase After CRANIOtomy) is a patient-oriented, prospective, exploratory cohort study.
Methods: Participants, interventions and outcomes Data will be collected from patients between 18 and 80 years old who receive MRI or CT follow-up after craniotomy for resection of a space occupying lesion (benign or malignant) or vascular procedure at the Department of Neurosurgery at the University Hospital Zurich
- Conditions
- Postoperative Pain, Postoperative Nausea
- Being tested
- Postoperative imaging with magnetic resonance imaging or computed tomography
- Keywords
- Magnetic resonance imaging, Craniotomy, Postoperative imaging
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative imaging with magnetic resonance imaging or computed tomographyRadiation
Postoperative imaging control with magnetic resonance or computed tomography after craniotomy for vascular or neurooncological operations.
| Study group | Role | What they receive |
|---|---|---|
| Early imaging: within 36 hours postoperatively. | Patients fulfilling eligibility criteria between 18 and 80 years old who receive MRI or CT follow-up after craniotomy for resection of a space occupying lesion (benign or malignant) or vascular within 36 hours after neurosurgical procedure. Receives: Radiation: Postoperative imaging with magnetic resonance imaging or computed tomography | |
| Late imaging: between 36 and 72 hours postoperatively | Patients fulfilling eligibility criteria between 18 and 80 years old who receive MRI or CT follow-up after craniotomy for resection of a space occupying lesion (benign or malignant) or vascular between 36 and 72 hours after neurosurgical procedure. Receives: Radiation: Postoperative imaging with magnetic resonance imaging or computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of the study is the difference in subjective distress after craniotomy, measured just before and after postoperative MRI or CT.
Subjective distress is evaluated as a combination of the results of the 3 scores: visual analogue scale for (VAS) pain, VAS for nausea and Body Part Discomfort score.
Measured: The measurements are taken up to 1 hour before and up to 1 hour after postoperative radiological imaging after craniotomy.
Secondary outcomes (2)
Patient specific secondary endpoint
Patient subjective interpretation of whether MRI control was performed at the correct interval. At the end of the questionnaire, patients will be asked to answer the following question:
In your opinion, should the MRI and/or CT scan have been performed earlier or later? The possible answers are:
- Yes, earlier;
- Yes, later;
- No, I am satisfied with the timing of the exam.
Measured: The measurement is taken up to 1 hour after postoperative radiological imaging after craniotomy.
Radiology specific secondary endpoints
Presence of residual tumor on MRI: yes or no. Presence of contrast enhancement on MRI (postoperative reactive change, not tumor specific): yes or no.
Presence of post-operative bleeding on CT or MRI: yes or no. Presence of postop-operative infarction on MRI: yes or no Residual perfusion of the aneurysm or AVM remnant on MRI or CT: yes or no.
Measured: The radiological evaluation of imaging after craniotomy is performed up to 12 hours after postoperative radiological examination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start20 Sep 2020
- Primary completion31 Jan 2023
- Study completion1 Feb 2023
Why it stopped: Failed resources.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112575
- Sponsor's protocol ID
- 2020-01590
- Acronym
- IPAST-CRANIO
- Status last verified
- Nov 2023
- First submitted
- 16 Sep 2021
- Last updated
- 7 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tosic L, Thoma M, Voglis S, Hofer AS, Bektas D, Pangalu A, Regli L, Germans MR. Evaluation of patient STress level caused by radiological Investigations in early Postoperative phase After CRANIOtomy (IPAST-CRANIO): protocol of a Swiss prospective cohort study. BMJ Open. 2022 Sep 21;12(9):e061452. doi: 10.1136/bmjopen-2022-061452.
PubMed 36130762
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patient Stress Level Caused by Radiological Investigations in Early Postoperative Phase After Craniotomy (IPAST-CRANIO): Protocol of a Swiss Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05112575
- Acronym / sponsor ID
- IPAST-CRANIO / 2020-01590
- Conditions
- Postoperative Pain, Postoperative Nausea
- Keywords
- Magnetic resonance imaging, Craniotomy, Postoperative imaging
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Failed resources.
- Enrolment
- 152 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 9 Nov 2021 (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.
Postoperative imaging after neurosurgical intervention is usually performed in the first 72 hours after surgery. Postoperative radiological examinations in the first 72 hours provide accurate assessment of postoperative resection status. On the other side is frequently reported by patients that the earlier postoperative examinations after craniotomy for tumor and vascular procedures are associated with distress, exertion, nausea, and pain. Therefore, psychological and physical stress on the patient could be a potential disadvantage of earlier (up to 36 hours postoperatively) follow-up. The goal of this study is to evaluate and determine the optimal time frame for postoperative imaging with MRI and CT in terms of medical and neuroradiological implications and patient's subjective stress.
The primary endpoint of the study is the extent of subjective distress due to postoperative MRI and CT monitoring in relation to the time interval after surgery Data will be prospectively collected from all patients aged 18 to 80 years who receive postoperative MRI or CT follow-up after craniotomy for resection of a cerebral tumor (benign and malignant) or vascular surgery.
This study determines, whether a timing of postoperative imaging can improve patient satisfaction and reduce pain, stress and discomfort caused by postoperative imaging. The outcome corresponds to the value-based medicine approach of modern patient-centred medicine. Results will be published in peer-reviewed journals and electronic patient data will be safely stored for 15 years.
Detailed description
Background and rationale Magnetic resonance imaging (MRI) after neurosurgical resection of a cerebral tumor is usually performed in the first 72 hours after surgery. 1-4 Accurate assessment of early postoperative resection status in brain tumors is mandatory for further treatment planning, e.g., delineation of the radiation field in radiotherapy, or reoperation for significant residual tumor. 5 Various MRI-sequences provide information on tumor size and location, as well as additional insight into secondary phenomena such as edema, hemorrhage, infarct, necrosis, and signs of increased intracranial pressure. 1, 3, 5, 6 The 72 hours' time window is crucial for accurate assessment of resection status and is additionally used for quality control of the neurosurgical procedure. 7 Postoperative MRI later than 72 hours after surgery can lead to false positive contrast enhancement due to absorption of contrast in the surgical area which can complicate the assessment of resection status. 1, 6 Postsurgical repair mechanisms at the resection site that result from hypervascularization and disruption of blood-brain barrier are probably responsible for this delayed enhancement. 7 The potential advantages of early imaging (within 36 hours after surgery) are better radiological assessment of the surgical site and earlier diagnosis of postoperative complications, such as infarcts, postoperative bleeding or edema. This may help in improving the postoperative management of patients with complications. Moreover, earlier information about the outcome of surgery could also lead to psychological relief for patients in the early postoperative period. Disadvantages of early postoperative examinations after craniotomy are frequently reported by patients and include distress, exertion, nausea, and pain during and after the examination. As such, psychological and physical patient stress could be a potential disadvantage of early (within 36 hours after surgery) MRI examination. An alternative image modality is Computed Tomography (CT), which may be less stressful for the patients because it takes only 5 to 10 minutes to complete the scan and the patients do not have to lie in small claustrophobic space compared to MRI. However, with this modality the postoperative resection status cannot reliably be assessed. To the authors knowledge, no previous literature has been published which addressed the stress factors during postoperative imaging. To authors opinion, a more patient-centered view regarding postoperative MRI investigation needs more clarification, so the authors want to investigate the intensity of patient stress after postoperative imaging at different intervals from surgery. With optimization of the time window of the MRI examination, the authors want to improve the psychological and physical patient stress, which may have a positive influence on early recovery. Additionally, establishing an optimal time window for postoperative MRI imaging will help in scheduling the examination before the elective surgical treatment. This will have a positive impact on preparing patients, radiology employees, nurses and physicians for a smooth and easy transport to and from the MRI examination.
Objectives The goal of this study is to assess whether early imaging with MRI (within 36 hours) after craniotomy is different regarding patient stress, than delayed imaging (between 36 and 72 hours). Secondly, the authors want to assess whether there is a difference in patient stress level between postoperative MRI and CT within 72 hours postoperatively.
The authors hypothesize that delayed imaging with MRI after craniotomy is more comfortable for patients without negative implication of radiological assessment, than imaging within 36 hours. Secondly, the authors hypothesize that postoperative MRI is more stressful for patients than CT.
Trial design The IPAST-CRANIO study (Evaluation of patient STress level caused by radiological Investigations in early Postoperative phase After CRANIOtomy) is a patient-oriented, prospective, exploratory cohort study.
Methods: Participants, interventions and outcomes Data will be collected from patients between 18 and 80 years old who receive MRI or CT follow-up after craniotomy for resection of a space occupying lesion (benign or malignant) or vascular procedure at the Department of Neurosurgery at the University Hospital Zurich
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early imaging: within 36 hours postoperatively. | – | Radiation: Postoperative imaging with magnetic resonance imaging or computed tomographyPatients fulfilling eligibility criteria between 18 and 80 years old who receive MRI or CT follow-up after craniotomy for resection of a space occupying lesion (benign or malignant) or vascular within 36 hours after neurosurgical procedure. |
| Late imaging: between 36 and 72 hours postoperatively | – | Radiation: Postoperative imaging with magnetic resonance imaging or computed tomographyPatients fulfilling eligibility criteria between 18 and 80 years old who receive MRI or CT follow-up after craniotomy for resection of a space occupying lesion (benign or malignant) or vascular between 36 and 72 hours after neurosurgical procedure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data will be collected from patients between 18 and 80 years old who receive MRI or CT follow-up after craniotomy for resection of a space occupying lesion (benign or malignant) or for any vascular procedure at the Department of Neurosurgery at the University Hospital Zurich
Key inclusion criteria (4 listed)
- Written consent of the patient
- Age between 18 and 80 years
- Planned for supra- or infratentorial (partial) resection of space occupying lesion (benign or malignant) or vascular neurosurgical procedure (clipping of an aneurysm, resection of an arteriovenous malformation, resection of cavernoma)
- Patients planned for MRI or CT follow-up within 72 hours after surgery
Key exclusion criteria (6 listed)
- No informed consent
- Operation using only one burr hole (e.g. biopsy)
- Not able to fill out the questionnaires due to cognitive impairment or aphasia
- Not understanding German or English language
- Contraindication for MRI examination
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 |
|---|---|---|
| Postoperative imaging with magnetic resonance imaging or computed tomographyPostoperative imaging control with magnetic resonance or computed tomography after craniotomy for vascular or neurooncological operations. | Radiation | Early imaging: within 36 hours postoperatively., Late imaging: between 36 and 72 hours postoperatively |
Primary outcome
The primary endpoint of the study is the difference in subjective distress after craniotomy, measured just before and after postoperative MRI or CT.
Time frame: The measurements are taken up to 1 hour before and up to 1 hour after postoperative radiological imaging after craniotomy.
Subjective distress is evaluated as a combination of the results of the 3 scores: visual analogue scale for (VAS) pain, VAS for nausea and Body Part Discomfort score.
2 secondary outcomes
Patient specific secondary endpoint
Time frame: The measurement is taken up to 1 hour after postoperative radiological imaging after craniotomy.
Radiology specific secondary endpoints
Time frame: The radiological evaluation of imaging after craniotomy is performed up to 12 hours after postoperative radiological examination.
Results and safety
The study was stopped early (reason given: Failed resources.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Background: PubMed 36130762Tosic L, Thoma M, Voglis S, Hofer AS, Bektas D, Pangalu A, Regli L, Germans MR. Evaluation of patient STress level caused by radiological Investigations in early Postoperative phase After CRANIOtomy (IPAST-CRANIO): protocol of a Swiss prospective cohort study. BMJ Open. 2022 Sep 21;12(9):e061452. doi: 10.1136/bmjopen-2022-061452.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Postoperative Pain and Postoperative Nausea, run by University of Zurich at 1 site in Switzerland.
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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 7 Dec 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 Switzerland. 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?
The study was stopped early (reason given: Failed resources.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint of the study is the difference in subjective distress after craniotomy, measured just before and after postoperative MRI or CT. (time frame: The measurements are taken up to 1 hour before and up to 1 hour after postoperative radiological imaging after craniotomy.). 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 NCT05112575, which also lists 1 linked publication.
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 7 Dec 2023.