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Clinical Trials/NCT05388786
NCT05388786
Enrolling By Invitation
Not Applicable

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

University of Southern California1 site in 1 country200 target enrollmentJune 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Consensus Development
Sponsor
University of Southern California
Enrollment
200
Locations
1
Primary Endpoint
Degree of consensus
Status
Enrolling By Invitation
Last Updated
3 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
June 1, 2023
End Date
December 15, 2024
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rene Sotelo

Professor of Clinical Urology

University of Southern California

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

Outcomes

Primary Outcomes

Degree of consensus

Time Frame: 1 month

The level of agreement for all statements achieving consensus from the expert panel; consensus is predefined as ≥ 80% of the panel rating a given statement

Study Sites (1)

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