Melanoma Clinical Trial

Complications and Adverse Events in Lymphadenectomy in the Inguinal Area

Summary

The investigators aim to create an effective and accurate method to report, define, and classify complications and adverse events during and after Inguinal lymph node dissection (ILND) as part of the staging and treatment for penile cancer, vulvar cancer, and melanoma. In turn, this will become an objective, efficient, and reproducible tool to facilitate comparisons across surgical approaches, techniques, and surgeons.

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Full Description

Inguinal lymph node dissection (ILND) has shown to be a necessary surgery from the oncology standpoint being extensively used as part of the staging process in malignancies of the penis, vulva, or melanoma. Moreover, the ILND has been shown to improve survival if performed in a timely manner. Yet, ILND is linked to a high rate of complications and adverse events.

Complications and adverse events' incidence are frequently used as surrogate markers of quality in surgery. However, there is tremendous heterogeneity in the report in such specifically for this procedure. Even though different classification and grading systems on surgical complications are available. There is a lack of standardization regarding the definition and classification to report ILND complications and adverse events leading to discrepancies across the literature, often interfering with the interpretation of surgical performance and quality.

This study will provide a systematic definition and classification of ILND complications and adverse events, ultimately improving the reporting of such conditions for future studies.

To create an effective and accurate method to report, define, and classify complications and adverse events during and after ILND as part of the staging and treatment for penile cancer, vulvar cancer, and melanoma. In turn, this will become an objective, efficient, and reproducible tool to facilitate comparisons across surgical approaches, techniques, and surgeons.

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Eligibility Criteria

Inclusion Criteria:

Experts in open inguinal lymphadenectomy
Experts in video endoscopic inguinal lymphadenectomy (VEIL)
Experts in robotic video endoscopic inguinal lymphadenectomy (R-VEIL)
Authors with at least one publication in ILND for penile cancer, vulvar cancer, or melanoma

Exclusion Criteria:

Panelists who were not able to commit to all rounds of the modified Delphi process will be excluded

Study is for people with:

Melanoma

Estimated Enrollment:

200

Study ID:

NCT05388786

Recruitment Status:

Enrolling by invitation

Sponsor:

University of Southern California

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There is 1 Location for this study

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University of Southern California
Los Angeles California, 90089, United States

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Estimated Enrollment:

200

Study ID:

NCT05388786

Recruitment Status:

Enrolling by invitation

Sponsor:


University of Southern California

How clear is this clinincal trial information?

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