Clinical Characteristics of Patients Under the Age 21 Years Who Underwent Gynecological Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Samsung Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00928369
First received: June 24, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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.


Condition
Demographic Findings
Presenting Symptoms on First Hospital Visit
Preoperative Radiologic Findings
Operation Method
Histologic Findings

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Clinical Characteristics of Adnexal Masses in Korean Pediatric and Adolescent Patients Under the Age 21 Years

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Estimated Enrollment: 494
Study Start Date: May 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   1 Year to 20 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00928369

Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: DooSeok Choi, MD, PhD Samsung Medical Center
  More Information

No publications provided

Responsible Party: DooSeok Choi, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00928369     History of Changes
Other Study ID Numbers: 2009-04-053
Study First Received: June 24, 2009
Last Updated: June 24, 2009
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014