NCT05388786

Complications and Adverse Events in Lymphadenectomy in the Inguinal Area

Complications and Adverse Events in Lymphadenectomy in the Inguinal Area: Delphi Consensus on Adverse Events Definition and Management

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Consensus Development

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-06-30
• Completion: 2024-12-15
• First posted: 2022-05-24
• Last updated: 2023-04-20

Locations

1 site across 1 country: United States