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

Completed

• Conditions: Gynecologic Cancer
• Interventions: Procedure: Laparoscopic ultra-radical lymph node debulking

• Registration Number: NCT05318170
• Lead Sponsor: University of Palermo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2022-04-04
• Study First Submitted QC: 2022-04-04
• Primary Completion: 2022-04-08
• Study First Posted: 2022-04-08
• Study Completion: 2022-04-11
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-13
• Last Update Posted: 2022-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 43

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women affected by gynecological cancer	Laparoscopic ultra-radical lymph node debulking	Women affected by gynecological cancer (cervical, endometrial, ovarian and vulvar cancer)

Primary Outcome Measures

Name	Time	Method
Complications	During the surgery and within 30 days after the surgery	Any complication occurred

Trial Locations

Locations (1)

University of Palermo; 🇮🇹 Palermo, Sicily, Italy