Laparoscopic Ultra-radical Lymph Node Debulking Using Yasargil Clamps (Yasargil-1)
NCT ID: NCT05318170
Last Updated: 2022-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
43 participants
OBSERVATIONAL
2022-04-01
2022-04-11
Brief Summary
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To date, few reports evaluated the use of minimally invasive surgery for lymph node debulking in gynecological cancer patients with metastatic bulky lymph nodes, with encouraging results, despite the small sample sizes. Nevertheless, new minimally invasive surgery techniques that may minimize intraoperative complications are necessary. Considering these elements, this multicenter retrospective analysis is aimed to evaluate intra- and post-operative surgical outcomes, after laparoscopic ultraradical lymph nodal debulking using Yasargil clamps in gynecological cancer patients with bulky lymph node metastases.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Women affected by gynecological cancer
Women affected by gynecological cancer (cervical, endometrial, ovarian and vulvar cancer)
Laparoscopic ultra-radical lymph node debulking
Laparoscopic ultra-radical lymph node debulking using Yasargil clamps
Interventions
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Laparoscopic ultra-radical lymph node debulking
Laparoscopic ultra-radical lymph node debulking using Yasargil clamps
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Performance status \> 2 according to Eastern Cooperative Oncology Group (ECOG) criteria
18 Years
80 Years
FEMALE
No
Sponsors
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Fondazione Policlinico Universitario A. Gemelli, IRCCS
UNKNOWN
Universita di Verona
OTHER
University of Palermo
OTHER
Responsible Party
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Antonio Simone Laganà
Principal Investigator
Principal Investigators
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Antonio Simone Laganà, M.D., Ph.D.
Role: STUDY_CHAIR
University of Palermo
Vito Chiantera
Role: STUDY_DIRECTOR
University of Palermo
Mariano Catello Di Donna
Role: PRINCIPAL_INVESTIGATOR
University of Palermo
Locations
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University of Palermo
Palermo, Sicily, Italy
Countries
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References
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Di Donna MC, Sozzi G, Cucinella G, Giallombardo V, Gallotta V, Uccella S, Garzon S, Scambia G, Lagana AS, Chiantera V. Laparoscopic Ultra-radical Lymph Node Debulking Using Yasargil Clamps for Gynecological Malignancies: Results from a Large, Multicenter, Retrospective Analysis. J Minim Invasive Gynecol. 2022 Sep;29(9):1083-1091. doi: 10.1016/j.jmig.2022.05.016. Epub 2022 May 29.
Other Identifiers
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Yasargil-1
Identifier Type: -
Identifier Source: org_study_id
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