Clinical Trials Directory

Trials / Completed

CompletedNCT05318170

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
Phase
Study type
Observational
Enrollment
43 (actual)
Sponsor
University of Palermo · Academic / Other
Sex
Female
Age
18 Years – 80 Years
Healthy volunteers

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

Interventions

TypeNameDescription
PROCEDURELaparoscopic ultra-radical lymph node debulkingLaparoscopic ultra-radical lymph node debulking using Yasargil clamps

Timeline

Start date
2022-04-01
Primary completion
2022-04-08
Completion
2022-04-11
First posted
2022-04-08
Last updated
2022-07-18

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT05318170. Inclusion in this directory is not an endorsement.