Complications and Adverse Events in Lymphadenectomy in the Inguinal Area

• Conditions: Consensus Development
• Interventions: Behavioral: Delphi Questionnaire

• Registration Number: NCT05388786
• Lead Sponsor: University of Southern California

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.

Study Timeline

• Study First Submitted: 2022-05-18
• Study First Submitted QC: 2022-05-18
• Study First Posted: 2022-05-24
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-18
• Last Update Posted: 2023-04-20
• Study Start: 2023-06-01
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Delphi Panel	Delphi Questionnaire	A team of experts in open inguinal lymphadenectomy, video endoscopic inguinal lymphadenectomy (VEIL), and robotic-assisted video endoscopic inguinal lymphadenectomy (R-VEIL) in the fields of General Surgery, Gynecology Oncology, Surgical Oncology, and Urology will be invited to participate. These experts are identified according to surgical experience, research, and academic interest.

Primary Outcome Measures

Name	Time	Method
Degree of consensus	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

Trial Locations

Locations (1)

University of Southern California; 🇺🇸 Los Angeles, California, United States