- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00928369
Clinical Characteristics of Patients Under the Age 21 Years Who Underwent Gynecological Surgery
Clinical Characteristics of Adnexal Masses in Korean Pediatric and Adolescent Patients Under the Age 21 Years
Study Overview
Status
Detailed Description
The incidence of gynecologic surgery during the pediatric and adolescent period remains low. In this age group, the causes of gynecologic surgery were usually divided into three parts, congenital anomalies, genital traumas, and pathologic lesions of genital tract including uterine bady and cervix, ovaries, fallopian tubes, vagina, and vulva. Among these, adnexal masses generally have been the most common cause of gynecologic surgery in the pediatric and adolescent patients. Adnexal lesions span a spectrum of pathology from functional (non-neoplastic), benign to highly aggressive malignant neoplasms. The actual incidence of adnexal lesions in the young women is unknown; however, of the ovarian neoplasms operated on during childhood or adolescence, 10-30% are malignant. Therefore, early detection and adequate management of adnexal lesions are prerequisite for the life saving and future preservation of fertility potential. But until now, there have been limited studies regarding the clinical characteristics of patients with adnexal mass during this period, and most studies have been conducted with small numbers of patients. Therefore, more informations regarding the clinical characteristics of patients with adnexal lesions are very important for the early diagnosis and adequate management of the adnexal lesions in children and adolescents.
In this study, we reviewed the clinical characteristics of 494 young Korean patients who took the operation in university hospital with adnexal lesions over the past 14 years.
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Young women up to 20 years of age who took the gynecologic surgery due to adnexal lesions at the department of Obstetrics and Gynecology, Samsung Medical Center, Seoul, Korea from January, 1995 through March, 2009 were included.
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: DooSeok Choi, MD, PhD, Samsung Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2009-04-053
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