This is a pilot study to test the short-term effectiveness of an alternative treatment approach for precancerous cells of the cervix. The study will also explore whether this new treatment is feasible to perform and if it is acceptable to patients.
Standard treatment for precancerous cells of the cervix is called electrosurgical excision procedure (LEEP). Standard LEEP involves treating the entire cervix using FDA-approved equipment. Focal LEEP utilizes the same surgery and the same equipment but only treats the visually unhealthy part of the cervix and not the entire cervix. Side effects and unusual symptoms will be monitored as well as the patient's thoughts and recommendations of the procedure. The total amount of time of study participation is six months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Focal LEEP may or may not cause less damage to the cervix versus standard LEEP. This could potentially be an advantage by avoiding future complications during pregnancy.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Number of cases of recurrent high-grade cervical intraepithelial neoplasia
Recurrence of high-grade cervical intraepithelial neoplasia will be determined from cytologic and/or histologic evidence collected six months following the focal LEEP procedure.
Time frame: 6 months
Acceptability of focal LEEP procedure
A 15-minute questionnaire will be conducted by phone with the patient.
Time frame: 2 weeks following focal LEEP procedure
Feasibility of focal LEEP of high-grade cervical intraepithelial neoplasia
A short feasibility questionnaire will be completed by the medical provider performing the focal LEEP procedure.
Time frame: Within 1 week following focal LEEP procedure
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