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Laparoscopic Ultra-radical Lymph Node Debulking Using Yasargil Clamps (Yasargil-1)

Evaluation of Surgical Outcomes After Laparoscopic Ultra-radical Lymph Node Debulking Using Yasargil Clamps for Gynecological Malignancies

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05318170
Enrollment
43
Registered
2022-04-08
Start date
2022-04-01
Completion date
2022-04-11
Last updated
2022-07-18

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

Conditions

Gynecologic Cancer

Keywords

Gynecological oncology, Gynecological cancers, Bulky lymph nodes, Laparoscopic ultra-radical lymph node debulking, Yasargil clamps, Complications, Surgical outcomes

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 occurs in 0.3% to 1.0% of laparoscopic procedures, with potentially lethal consequences. Vascular injuries are usually managed using coagulation, clamps or vascular sutures, but if these measures fail, laparotomy is inevitable. 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.

Interventions

PROCEDURELaparoscopic ultra-radical lymph node debulking

Laparoscopic ultra-radical lymph node debulking using Yasargil clamps

Sponsors

Fondazione Policlinico Universitario A. Gemelli, IRCCS
CollaboratorUNKNOWN
Universita di Verona
CollaboratorOTHER
University of Palermo
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years

Inclusion criteria

* 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 criteria

* Disease-free interval \< 6 months and/or * Performance status \> 2 according to Eastern Cooperative Oncology Group (ECOG) criteria

Design outcomes

Primary

MeasureTime frameDescription
ComplicationsDuring the surgery and within 30 days after the surgeryAny complication occurred

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026