Complications and Adverse Events in Lymphadenectomy in the Inguinal Area

NCT05388786 | Unknown

• 1 other identifier: UP-22-00368
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Consensus Development

Outcome Measures

Primary Outcomes (1)

• Degree of consensus

  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

  1 month

Study Arms (1)

Delphi Panel

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.

Behavioral: Delphi Questionnaire

Interventions

Delphi Questionnaire BEHAVIORAL

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.

Delphi Panel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

University of Southern California

Los Angeles, California, 90089, United States

Location

Related Publications (6)

• Chipollini J, Tang DH, Gilbert SM, Poch MA, Pow-Sang JM, Sexton WJ, Spiess PE. Delay to Inguinal Lymph Node Dissection Greater than 3 Months Predicts Poorer Recurrence-Free Survival for Patients with Penile Cancer. J Urol. 2017 Dec;198(6):1346-1352. doi: 10.1016/j.juro.2017.06.076. Epub 2017 Jun 23.

  PMID: 28652123 BACKGROUND

• Gkegkes ID, Minis EE, Iavazzo C. Robotic-assisted inguinal lymphadenectomy: a systematic review. J Robot Surg. 2019 Feb;13(1):1-8. doi: 10.1007/s11701-018-0823-4. Epub 2018 May 5.

  PMID: 29730734 BACKGROUND

• Munoz Guillermo V, Rosino Sanchez A, Rivero Guerra A, Barcelo Bayonas I, Pardo Martinez A, Jimenez Peralta D, Carrillo George C, Pietricica BN, Izquierdo Morejon E, Cruces de Abia FI, Romero Hoyuela A, Hita Villaplana G, Fernandez Aparicio T. [Video endoscopic inguinal lymphadenectomy in penile cancer: Systematic review.]. Arch Esp Urol. 2019 Dec;72(10):992-999. Spanish.

  PMID: 31823847 BACKGROUND

• Mitropoulos D, Artibani W, Graefen M, Remzi M, Roupret M, Truss M; European Association of Urology Guidelines Panel. Reporting and grading of complications after urologic surgical procedures: an ad hoc EAU guidelines panel assessment and recommendations. Eur Urol. 2012 Feb;61(2):341-9. doi: 10.1016/j.eururo.2011.10.033. Epub 2011 Oct 29.

  PMID: 22074761 BACKGROUND

• Dindo D, Clavien PA. What is a surgical complication? World J Surg. 2008 Jun;32(6):939-41. doi: 10.1007/s00268-008-9584-y. No abstract available.

  PMID: 18414942 BACKGROUND

• Nabavizadeh R, Petrinec B, Necchi A, Tsaur I, Albersen M, Master V. Utility of Minimally Invasive Technology for Inguinal Lymph Node Dissection in Penile Cancer. J Clin Med. 2020 Aug 3;9(8):2501. doi: 10.3390/jcm9082501.

  PMID: 32756502 RESULT

Study Officials

• Rene Sotelo, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

• Giovanni Cacciamani, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Urology

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 24, 2022
• Study Start: June 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 15, 2024
• Last Updated: April 20, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)