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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00928369
Other study ID # 2009-04-053
Secondary ID
Status Active, not recruiting
Phase N/A
First received June 24, 2009
Last updated June 24, 2009
Start date May 2009
Est. completion date December 2009

Study information

Verified date June 2009
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Observational

Clinical Trial Summary

Young patients with adnexal lesions may have variable presenting symptoms. In this study, we reviewed the clinical characteristics of young Korean patients who took the operation in university hospital with adnexal lesions over the past 14 years.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 494
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Female
Age group 1 Year to 20 Years
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Samsung Medical Center