Cryotherapy for Human Papillomavirus Clearance in Biopsy-confirmed Cervical Low-grade Squamous Intraepithelial Lesions
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Purpose
Persistent human papillomavirus (HPV) infections is the single necessary cause of cervical cancer. Cervical cancer is still the major health problem in the developing countries. It has been the first rank women's cancer in Thailand for many decades. Approximately 10-20% of Thai women have the high-risk HPV (HR-HPV) infections in their cervices. This will frequently lead to low-grade squamous intraepithelial lesions (LSILs) (10%), high-grade squamous intraepithelial lesions (HSILs) (0.8%), and finally, cervical cancers (0.16%) within 10-20 years. The treatment options for LSILs are either observation or ablative surgery. However, in our institute, cryotherapy, which is the one of ablative surgery, is more frequently used to comfort our women. It is not only effective but safe with only minimal side effects; watery leukorrhea for 2-4 weeks, and local cervical infection not more than 1%. Contraindication to this procedure are active cervical infection, lesion of 2 mm-larger than probe, lesion inside cervical os and suspected cervical cancer. Additionally, in developing countries such as Thailand, this treatment is safe, acceptable, feasible and effective. Patients with LSILs could also have this treatment in some rural area from the 10-days trained nurses. Fortunately, recent reports showed that cryotherapy has abilities not only in clearing LSILs but also clearing the HPV infections, its necessary cause. However, there are no randomized controlled trial compared its clearing ability between observation and cryotherapy. Therefore, a randomized controlled trial is needed to demonstrate that. Findings from this trial will contribute enormously to older women who already get infected by HPV. Aside from preventing cervical cancer in treated woman, cryotherapy could also give her relief from worrying about having a time-bomb like HPV infection in her cervix.
| Condition | Intervention |
|---|---|
|
Human Papillomavirus Clearance at 12 Months |
Procedure: Cryotherapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Cryotherapy for Human Papillomavirus Clearance in Biopsy-confirmed Cervical Low-grade Squamous Intraepithelial Lesions: a Randomized Controlled Trial |
- Number of Patients With Human Papillomavirus Clearance [ Time Frame: 12 months ] [ Designated as safety issue: No ]At 12 months after treatment, a patient with negative results for HPV testing of previous types was considered as a clearance.
| Enrollment: | 100 |
| Study Start Date: | December 2007 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Double-freezing cryotherapy was done within one month after the primary hpv testing was positive. Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
|
Procedure: Cryotherapy
Double freezing technique
Other Name: Cryosurgery
|
|
No Intervention: B
Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Biopsy-confirmed LSIL patients
- Age more than 30 years-old
- Baseline HPV testing is positive.
- Be able to give their informed consent to this study.
Exclusion Criteria:
- Having active cervical infection
- Having lesion of 2 mm-larger than probe
- Having lesion inside cervical os
- Having suspected cervical cancer lesion
Contacts and Locations| Thailand | |
| Srinagarind Hospital, Faculty of Medicine, Khon Kaen University | |
| Muang, Khon Kaen, Thailand, 40002 | |
| Principal Investigator: | Bandit Chumworathayi, MD | Gynecologic Oncology Division, OBGYN Department, Faculty of Medicine, Khon Kaen University |
More Information
Additional Information:
No publications provided by Khon Kaen University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Clinical Epidemiology Unit (CEU), Faculty of Medicine, Khon Kaen University, Thailand |
| ClinicalTrials.gov Identifier: | NCT00566579 History of Changes |
| Other Study ID Numbers: | HE500830 |
| Study First Received: | November 30, 2007 |
| Results First Received: | June 1, 2010 |
| Last Updated: | August 2, 2010 |
| Health Authority: | Thailand: Khon Kaen University Ethics Committee for Human Research |
Keywords provided by Khon Kaen University:
|
Human papillomavirus Clearance Cryotherapy |
Additional relevant MeSH terms:
|
Uterine Cervical Dysplasia Precancerous Conditions Neoplasms |
Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 19, 2013