Feasibility of the Management of Severe Cervical Dysplasia in a Single Visit

University of California, Irvine

Overview

1. Implement a single-visit program (SVP) for cervix cancer prevention in clinics serving a multi-ethnic population of women; 2. Set up an efficient system for interpretation of Pap smears for patients in the SVP that will minimize waiting time; 3. Determine the follow-up rates and compare them between women assigned to the SVP and a usual care program (UCP); 4. Determine satisfaction and compare it between women assigned to the SVP and the UCP; 5. Determine the cost-effectiveness and compare it between the SVP and UCP

Women were recruited from underserved communities to participate in this single visit cervix cancer project. Large loop electrosurgical excision procedure (LEEP) was performed on SVP subjects with either a diagnosis of HGSIL/AGUS or suspicion of carcinoma. All other subjects with abnormal Papanicolaou smears were referred to our abnormal cytology clinics or received care in the community.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Conditions

Cervical Intraepithelial Neoplasia

Interventions

Large loop electrosurgical excisionPROCEDURE

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Older than 18 years * No history of invasive cervical cancer * Not pregnant Exclusion Criteria: * Absence of a cervix * Abnormal vaginal bleeding * Cervical cancer screening within the previous 12 months * A known bleeding disorder * Reluctance to be randomized * Unwillingness to follow the study protocol

Locations (1)

University of California, Irvine

Orange, California, United States

Data from ClinicalTrials.gov

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