Optimized Surgical Workflow and Real-Time Quality Assessment via Intraoperative Digital Volume Tomography

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00037762

Enrollment

Registered

2025-10-23

Start date

2025-11-01

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I61.0

Interventions

Group 1: intraoperative CBCT (Cone Beam Computertomographie) Group 2: historical control group

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - intracerebral hemorrhage with indication for surgical evacuation - Shunt implantation procedures - stereotactic biopsies or biopsies performed using Varioguide

Exclusion criteria

Exclusion criteria: - Minors (under 18 years of age)

Design outcomes

Primary

Measure	Time frame
Number of immediate intraoperative revisions following iCBCT	—

Secondary

Measure	Time frame
- Duration of surgery (measured in minutes from skin incision to skin closure) - Radiation exposure (measured in mSv or DLP) - Image quality of intraoperative CBCT compared to postoperative CT (subjectively rated by four independent neuroradiologists/neurosurgeons) - Rate of revision surgeries within 72 hours postoperatively - Pre-, intra-, and postoperative hematoma volume - Occurrence of postoperative complications (e.g. rebleeding, infections) - Logistical parameters such as repositioning requirements, transport time, and OR occupancy - Costs	—

Measure

Time frame

- Duration of surgery (measured in minutes from skin incision to skin closure) - Radiation exposure (measured in mSv or DLP) - Image quality of intraoperative CBCT compared to postoperative CT (subjectively rated by four independent neuroradiologists/neurosurgeons) - Rate of revision surgeries within 72 hours postoperatively - Pre-, intra-, and postoperative hematoma volume - Occurrence of postoperative complications (e.g. rebleeding, infections) - Logistical parameters such as repositioning requirements, transport time, and OR occupancy - Costs

—

Countries

Germany

Contacts

Public ContactLina-Elisabeth Qasem

Klinik für Neurochirurgie

qasem@med.uni-frankfurt.de069/63015295

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026