Evaluation of Patient Stress Level Caused by Radiological Investigations in Early Postoperative Phase After Craniotomy

NCT05112575 | Terminated

• 1 other identifier: 2020-01590
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Postoperative Pain; Postoperative Nausea

Keywords

Magnetic resonance imaging; Craniotomy; Postoperative imaging

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  The measurement is taken up to 1 hour after postoperative radiological imaging after craniotomy.

• Radiology specific secondary endpoints

  The radiological evaluation of imaging after craniotomy is performed up to 12 hours after postoperative radiological examination.

Study Arms (2)

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.

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.

Radiation: Postoperative imaging with magnetic resonance imaging or computed tomography

Interventions

Postoperative imaging with magnetic resonance imaging or computed tomography RADIATION

Postoperative imaging control with magnetic resonance or computed tomography after craniotomy for vascular or neurooncological operations.

Early imaging: within 36 hours postoperatively.; Late imaging: between 36 and 72 hours postoperatively

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Department of Neurosurgery, University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 36130762 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: November 9, 2021
• Study Start: September 20, 2020
• Primary Completion: January 31, 2023
• Study Completion: February 1, 2023
• Last Updated: December 7, 2023

Record last verified: 2023-11

Locations

CH (1)