跳至主要内容
临床试验/NCT05388786
NCT05388786Enrolling By Invitation不适用

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

University of Southern California1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
200
试验地点
1
主要终点
Degree of consensus

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Panelists who were not able to commit to all rounds of the modified Delphi process will be excluded

结局指标

主要结局

Degree of consensus

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rene Sotelo

Professor of Clinical Urology

University of Southern California

研究点 (1)

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