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

• Conditions: Q67.0; Reconstruction with local flap of muscles or fascia, as well as mircrovascular anastomosis in free tissue transfer; C50; N62; Malignant neoplasm of breast; Hypertrophy of breast; Other congenital malformations of breast; Facial asymmetry; Q83.8; E88.1

• Registration Number: DRKS00009014
• Lead Sponsor: Handchirurgie, Plastische Chirurgie und Ästhetische Chirurgie am Klinikum der Ludwig-Maximilians-Universität München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-15
• Results First Posted: 2016-04-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 200

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

• 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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome:<br>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.

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome: the form and volume changes over 2 years