Verification of clinical efficacy of surgical planning using 3D printed models of intracranial aneurysms: randomized controlled study
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0008646
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
The usefulness of the model was determined based on treatment outcomes, patient counseling, and physician education. Compared to the control group, the total operation time was shorter (median 91 minutes versus 125 minutes; P = 0.02) and the volume of blood loss was lower (median 119.6 ml versus 234.0 ml; P = 0.01) in the case group. Patients’ understanding of the operation improved significantly after counseling using 3D printed models in all aspects (P = 0.02)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 28
1) patients diagnosed with a single unruptured IA in the anterior circulation on magnetic resonance angiography or computed tomography angiography and digital subtraction angiography with 3D reconstructed imaging; 2) patients with IAs inappropriate for endovascular intervention in terms of shape, access, underlying medical conditions, and patient preference; 3) patients with a tolerable healthy condition with a Karnofsky Performance Scale = 70 and modified Rankin Scale = 2; and 4) patients who agreed to surgical clipping via keyhole craniotomy
(1) In cases where the researchers determine that an evaluation of effectiveness is not necessary.
(2) In cases where the patient or their guardian does not provide consent.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective indicators (surgical duration, immediate postoperative pain, degree of aneurysm occlusion, length of stay in the intermediate care unit, total hospitalization period, amount of bleeding, etc.).
- Secondary Outcome Measures
Name Time Method Subjective indicators (survey questionnaire assessing patient description, education, and level of assistance during surgery).