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

University of California Irvine (UCI)

Status and phase: Completed; Phase 3

Conditions: Cervical Intraepithelial Neoplasia

Treatments: Procedure: Large loop electrosurgical excision

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00237562

R01CA076501

Details and patient eligibility

About

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

Full description

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.

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)