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Optimal volume management and outcome in free flap surgery

Optimal volume management and outcome in free flap surgery - OptiVol

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00041148
Enrollment
450
Registered
2026-07-30
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Free Flap Surgery

Interventions

Group 1: The OptiVOL project is designed as a retrospective observational study. Clinical data from patients who underwent elective free flap transfer for soft tissue reconstruction at the Unfallkrank

Sponsors

Unfallkrankenhaus Berlin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Free flap reconstruction performed in the following specialties: Oral and Maxillofacial Surgery Hand and Plastic Surgery

Exclusion criteria

Exclusion criteria: Pregnancy Ongoing therapeutic anticoagulation Age <18 years (or Age under 18 years)

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the intraoperative fluid and catecholamine requirements during elective free flap reconstruction necessary to maintain haemodynamic homeostasis, as assessed by clinical parameters. Furthermore, the study will investigate the association between the extent of intraoperative fluid administration and catecholamine requirements and the incidence of postoperative flap loss, as well as the number of revision surgeries. The study parameters will be collected retrospectively from the hospital documentation system and analysed statistically.

Secondary

MeasureTime frame
The secondary endpoints include the assessment of changes in arterial blood gas base excess and the measurement of inflammatory markers (leukocyte count and C-reactive protein [CRP]). For each of these parameters, the association with the extent of intraoperative fluid administration and catecholamine requirements will also be evaluated. The study parameters will be collected retrospectively from the hospital documentation system and analysed statistically.

Countries

Germany

Contacts

Public ContactAdina Bathel

Unfallkrankenhaus Berlin

adina.bathel@ukb.de+49 30 5681 5148

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026