Skip to content

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05388786
Enrollment
200
Registered
2022-05-24
Start date
2023-06-01
Completion date
2024-12-15
Last updated
2023-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Consensus Development

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.

Interventions

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

University of Southern California
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Degree of consensus1 monthThe level of agreement for all statements achieving consensus from the expert panel; consensus is predefined as ≥ 80% of the panel rating a given statement

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026