Establishment of an Objectively Assistive Intraoperative System (Optical Measuring Technology) for 3D Visualisation and Volumetry in Reconstructive Surgeries

Establishment of an Objectively Assistive Intraoperative System (Optical Measuring Technology) for 3D Visualisation and Volumetry in Reconstructive Surgeries - 3DIO

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00009014

Enrollment

285

Registered

2015-10-15

Start date

2016-02-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Reconstruction with local flap of muscles or fascia, as well as mircrovascular anastomosis in free tissue transfer C50 N62 Q83.8 Q67.0 E88.1 E88.2

Interventions

Group 1: Observation study for 3D Surface Imaging: pre-, intra and postoperativ 3D Scan (follow-up scan after: 1 day, 4 days, 7 days, 14 days, 1 month, 1.5 months, 3 months, 6 months, 12 months, 18 mo

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Male and female aged 18 to 75; the unter health condition named cases for surgery of face, breast, abdomen and limbs; written consent and cooperative patient

Exclusion criteria

Exclusion criteria: • Previous surgery in the assessed area with extensive scaring and contraction which may bias correct evaluation • physiological problems hindering correct placement and mobilisation on the operation table for anaesthetists • patients undergoind hormon-therapy or having hormon related diseases (such as endocrine gynecomastia, Cushing) at the time of consultation • patients unable to undergo surgery • patients unable to attend all follow-ups • pregnancy and lactation period • drug abuse • previous surgery or sever disease of cardiovascular system, endocrinological problems, central nerve system, systemic, malignant, and autoimmune diseases • diseases with blood clotting disorders and allergic response to medication or antibiotics • psychiatric pre-existing conditions limiting participation in the study or follow-up

Design outcomes

Secondary

Measure	Time frame
Secondary Outcome: the form and volume changes over 2 years	—

Primary

Measure	Time frame
Primary Outcome: The intraoperative and postoperative 3D scans (1 day, 4 days, 7 days, 14 days, 1 month, 1.5 months, 3 months, 6 months, 12 months, 18 months, 24 months) with statistically non-significant difference between the tested 3D Imaging systems (Artec Eva®, Vectra H2®; Vectra XT®, Sense®, iSense®) and the Vectra System, as well as MRI and intraoperative reference values for each follow-up day.	—

Measure

Time frame

Primary Outcome: The intraoperative and postoperative 3D scans (1 day, 4 days, 7 days, 14 days, 1 month, 1.5 months, 3 months, 6 months, 12 months, 18 months, 24 months) with statistically non-significant difference between the tested 3D Imaging systems (Artec Eva®, Vectra H2®; Vectra XT®, Sense®, iSense®) and the Vectra System, as well as MRI and intraoperative reference values for each follow-up day.

—

Countries

Germany

Contacts

Public ContactRiccardo Enzo Giunta

Handchirurgie, Plastische Chirurgie und Ästhetische Chirurgie am Klinikum der Universität München

sek.handplastchir@med.uni-muenchen.de+49 89 4400 32671

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026