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Clinical Parameters Predicting Unsatisfactory Cervicovaginal Cytology in Conventional Smears

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00985309
First Posted: September 28, 2009
Last Update Posted: September 28, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Taichung Veterans General Hospital
  Purpose
According the terminology of Bethesda 2001, the unsatisfactory cervical cytology can be categorized into specimen rejected, or specimen processed and examined, but unsatisfactory for evaluation of epithelial abnormality. Most of the unsatisfactory cervical cytology was due to scanty epithelial cells, which was defined by less than an estimated 8,000 to 12,000 well-visualized squamous cells for conventional smears. Follow-up of unsatisfactory smear found an increased rate of cervical preinvasive and invasive lesions. Thus, an unsatisfactory smear deserves careful follow-up and studies. Although the Bethesda system allows criteria modification in cases of hysterectomy, pelvic irradiation therapy, or chemotherapy, no studies investigated the clinical factors related to the incidence of unsatisfactory smear. Thus, the investigators designed this trial to study the clinical factors relating to unsatisfactory cervicovaginal smear.The list of patients who received Papanicolaou smear between March 2006 and August 2006 in our hospital will be obtained from the Pathological Department first. Then the investigators will review the medical records from HIS system and pathologic files of these patients. On estimation, 7,437 cases will be enrolled for analysis. Clinical parameters for analysis include: age, gravidity, parity, abortion, menopause, location of Pap smear, history of pelvic malignancy, pelvic irradiation, cervical conization, hysterectomy; at pregnancy; three months postpartum; vaginal bleeding, vaginal abnormal discharge, intrauterine device, and cervical polyp found during pelvic examinations. Patients who missed any of above data will be excluded for analysis. The investigators will use univariate and multivariate analysis for data processing and statistic analysis to find out the relationship between clinical parameters and unsatisfactory cervicovaginal Pap smears.

Condition
Unsatisfactory Pap Smear

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by Taichung Veterans General Hospital:

Primary Outcome Measures:
  • unsatisfactory Pap smear rates in various clinical conditions

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A cohort of consecutive patients who received conventional Pap smear between March 2006 and August 2006 in Taichung Veterans General Hospital
Criteria

Inclusion Criteria:

  • A cohort of consecutive patients who received conventional Pap smear between March 2006 and August 2006 in Taichung Veterans General Hospital

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00985309


Locations
Taiwan
Department of OB/GYN, Taichung Veterans General Hospital
Taichung, Taiwan, 407
Sponsors and Collaborators
Taichung Veterans General Hospital
  More Information

Responsible Party: Chien-Hsing Lu, Department of OB/GYN, Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT00985309     History of Changes
Other Study ID Numbers: C08213
First Submitted: September 24, 2009
First Posted: September 28, 2009
Last Update Posted: September 28, 2009
Last Verified: September 2009

Keywords provided by Taichung Veterans General Hospital:
unsatisfactory
Pap smear