Vulvar Paget Disease

Completed

• Conditions: Vulvar Paget's Disease

• Registration Number: NCT03900975
• Lead Sponsor: University Hospital, Ghent

Brief Summary

In this study only women with vulvar paget disease will be included and will be analysed retrospectively. Vulvar paget disease patients are frequently treated with surgical resection of the affected tissue. During a surgical treatment surgical margins are frequently positive. Recidives are seen frequently after surgical treatment or the development of other pathologies such as vulvar carcinoma. In this study the outcome of the vulvar paget disease will be analysed and compared between the participants. It's primary goal is to create a better view on the outcome and the prognosis to prevent e.g. complications in the future.

Detailed Description

In this study only women with vulvar paget disease will be included and will be analysed retrospectively. Vulvar paget disease patients are frequently treated with surgical resection of the affected tissue. During a surgical treatment surgical margins are frequently positive. Recidives are seen frequently after surgical treatment or the development of other pathologies such as vulvar carcinoma. In this study the outcome of the vulvar paget disease will be analysed and compared between the participants. It's primary goal is to create a better view on the outcome and the prognosis to prevent e.g. complications in the future.

All the information of the patients will be gathered retrospectively from their medical file , after they gave their consent.

Study Timeline

• Study Start: 2018-09-25
• Study First Submitted: 2018-12-14
• Study First Submitted QC: 2019-04-01
• Study First Posted: 2019-04-03
• Primary Completion: 2020-06-30
• Study Completion: 2020-07-31
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-09
• Last Update Posted: 2020-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 8

Inclusion Criteria

• Vulvar Paget disease

Exclusion Criteria

• No exclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Type of complications after the treatment of vulvar Paget disease	Max. 10 years after treatment	Type of complications after treatment
Number of complications after the treatment of vulvar Paget disease	Max. 10 years after treatment	Number of complications after treatment

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, East Flanders, Belgium