ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00928369
Recruitment Status : Unknown
Verified June 2009 by Samsung Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : June 25, 2009
Last Update Posted : June 25, 2009
Sponsor:
Information provided by:
Samsung Medical Center

Brief 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.

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

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 : Observational
Estimated Enrollment : 494 participants
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
Study Start Date : May 2009
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   1 Year to 20 Years   (Child, Adult)
Sexes 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.


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): NCT00928369


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

Responsible Party: DooSeok Choi, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00928369     History of Changes
Other Study ID Numbers: 2009-04-053
First Posted: June 25, 2009    Key Record Dates
Last Update Posted: June 25, 2009
Last Verified: June 2009

Additional relevant MeSH terms:
Signs and Symptoms