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Complications and Adverse Events in Lymphadenectomy in the Inguinal Area

NCT05388786 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2023-04-20

No results posted yet for this study

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.

Conditions

  • Consensus Development

Interventions

BEHAVIORAL

Delphi Questionnaire

An invitation email, including a link to the survey, will be sent to the panel of experts in ILND for penile cancer, vulvar cancer, and melanoma. The Delphi questionnaire will be administered via Welphi.com. In the first survey, panel members will outline the ILND complications and adverse events definition and classification with a series of 5-point Likert scale assessments and options for free-text responses relating to the surgeon's perception. The experts will fill out the online questionnaire. For the questions that do not reach a consensus of more than 80% in the first round or need further explanation, additional rounds of the survey may be performed.

Sponsors & Collaborators

  • University of Southern California

    lead OTHER

Principal Investigators

  • Rene Sotelo, MD · University of Southern California

  • Giovanni Cacciamani, MD · University of Southern California

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2024-06-30
Completion
2024-12-15

Countries

  • United States

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 NCT05388786 on ClinicalTrials.gov