Status:
COMPLETED
Laparoscopic Ultra-radical Lymph Node Debulking Using Yasargil Clamps (Yasargil-1)
Lead Sponsor:
University of Palermo
Collaborating Sponsors:
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Universita di Verona
Conditions:
Gynecologic Cancer
Eligibility:
FEMALE
18-80 years
Brief Summary
Although several studies have demonstrated the overall benefits of a laparoscopic approach for pelvic and para-aortic lymphadenectomy, complications remain a challenging scenario. Vascular injury occu...
Eligibility Criteria
Inclusion
- At least one bulky lymph node with size ≥ 25 mm
- Age \> 18 years
- Body mass index (BMI) \< 40 kg/m²
- Absence of abdominal adhesion syndrome and intraperitoneal dissemination at the time of laparoscopic evaluation
Exclusion
- Disease-free interval \< 6 months and/or
- Performance status \> 2 according to Eastern Cooperative Oncology Group (ECOG) criteria
Key Trial Info
Start Date :
April 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 11 2022
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT05318170
Start Date
April 1 2022
End Date
April 11 2022
Last Update
July 18 2022
Active Locations (1)
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1
University of Palermo
Palermo, Sicily, Italy, 90133