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

NCT05318170 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 43

Last updated 2022-07-18

No results posted yet for this study

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.

Conditions

  • Gynecologic Cancer

Interventions

PROCEDURE

Laparoscopic ultra-radical lymph node debulking

Laparoscopic ultra-radical lymph node debulking using Yasargil clamps

Sponsors & Collaborators

  • Fondazione Policlinico Universitario A. Gemelli, IRCCS

    collaborator UNKNOWN

  • Universita di Verona

    collaborator OTHER

  • University of Palermo

    lead OTHER

Principal Investigators

  • Antonio Simone Laganà, M.D., Ph.D. · University of Palermo

  • Vito Chiantera · University of Palermo

  • Mariano Catello Di Donna · University of Palermo

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2022-04-08
Completion
2022-04-11

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05318170 on ClinicalTrials.gov