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A Randomized Controlled Trial Comparing SynchroSeal and Monopolar Scissors for Parenchymal Transection in Robotic Liver Resection

A Randomized Controlled Trial Comparing SynchroSeal and Monopolar Scissors for Parenchymal Transection in Robotic Liver Resection - SmartCut

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00037868
Enrollment
62
Registered
2025-09-09
Start date
2026-01-16
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

D13.4 C22 C78.7

Interventions

Group 1: Study Intervention: Use of Monopolar Scissors (Intuitive Surgical Inc., Sunnyvale, CA, USA) for parenchymal transection during RLR. Group 2: Control Intervention: Use of SynchroSeal (Intuitiv

Sponsors

Chirurgische Klinik der Universitätsmedizin Mannheim
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Age equal to or greater than 18 years • Elective RLR • Ability to understand the character and individual consequences of the clinical trial • Written informed consent

Exclusion criteria

Exclusion criteria: • ASA = 4 • Impaired mental state or incompetence in understanding the German language • Expected lack of compliance

Design outcomes

Primary

MeasureTime frame
To assess the clinical performance of monopolar scissors and SynchroSeal with respect to intraoperative blood loss during the transection phase of RLR.

Secondary

MeasureTime frame
To compare the incidence of postoperative bile leakage between both devices, defined according to the criteria of the International Study Group of Liver Surgery (ISGLS, grades B and C only).

Countries

Germany

Contacts

Public ContactSchaima Abdelhadi

Chirurgische Klinik der Universitätsmedizin Mannheim

schaima.abdelhadi@umm.de06213832225

Outcome results

None listed

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