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OpenTrials
Completed

NCT Number: NCT05318170

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

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.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Palermo

Palermo, Sicily, 90133, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic ultra-radical lymph node debulking

Procedure

Laparoscopic ultra-radical lymph node debulking using Yasargil clamps

Primary outcomes

  1. Complications

    Time frame: During the surgery and within 30 days after the surgery

    Any complication occurred

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Universita di Verona

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 8, 2022
Registry last updated
Jul 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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