Factors Associated With Residual Disease In The Central Cone

Completed

• Conditions: Cervical Intraepithelial Neoplasia

• Registration Number: NCT03788850
• Lead Sponsor: National Institute of Cancerología

Brief Summary

Cervical conization using the loop electrosurgical excision procedure (LEEP) is the standard treatment for patients with high-grade cervical intraepithelial neoplasia. Several studies have shown that excising a central cone reduces the rate of positive endocervical margins. The purpose of this study is to identify clinicopathological factors associated with residual disease in the central cone and to develop a predictive model to better determine which patients may require this additional procedure.

Detailed Description

This study pretends to create a retrospective database including all patient who underwent a loop electrosurgical excision procedure by treatment for high-grade cervical intraepithelial neoplasia and create a a predictive model for top-hat resection in patients with high grade CIN

Study Timeline

• Study Start: 2006-01-01
• Primary Completion: 2011-12-31
• Study Completion: 2016-08-15
• Study First Submitted: 2018-11-05
• Study First Submitted QC: 2018-12-26
• Study First Posted: 2018-12-28
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-25
• Last Update Posted: 2020-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 397

Inclusion Criteria

• patients who underwent a loop electrosurgical excision procedure (LEEP)

Exclusion Criteria

• a diagnosis of micro-invasion or nonsquamous histology
• less than six months of follow-up
• incomplete information in their clinical charts.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identify the clinical and pathologic factors associated with residual disease	1month	Whit the variables identified as factors associated with the residual disease develop a predictive model to determine which individuals may require additional procedures in the uterine cervix to ensure negative margins.