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Completed

NCT Number: NCT02069171

Cross-sectional and Questionnaire Study for Leg Lymphedema

The purpose of this study is to identify the incidence,feature,clinical significance for leg lymphedema after gynecologic cancer treatment.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

Medical records will reviewed. And all patients who met the inclusion criteria will contacted by a telephone call by a clinical research coordinator. The telephone interview questionnaire for Lower Extremity Edema (LEE) and gynecologic cancer lymphedema questionnaire (GCLQ) will t take approximately 20-30 min to complete. The questionnaire for LEE included onset, severity, location, duration, and management. Patients will also questioned concerning deep vein thrombosis to exclude other causes of LEE. LEE is defined as subjective edema of lower extremity based on patients' complaint. LLL is defined based on a clinical diagnosis of lymphedema by a physician.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion criteria
  • the patient who gynecologic cancer treatment at National Cancer Center , Korea(2001~2011)
  • no active cancer treatment at the moment
  • available telephone communication
  • exclusion criteria 1. The patient unlikely to comply with the protocol

<More information by cancer type>

  • early ovarian cancer group Inclusion criteria were early stage epithelial ovarian cancer*, no active treatment, available telephone communication with patients, and ability and willingness to provide verbal informed consent.

*early ovarian cancer (FIGO stage I and II) at National Cancer Center, Korea who underwent cytoreductive and staging surgery between January 2001 and December 2010

  • locally advanced cervical cancer group patients with locally advanced cervical cancer who treatment at National Cancer Center, Korea between October 2001 and July 2007. Of 222 patients with locally advanced cervical cancer, 74 patients were underwent pretreatment laparoscopic surgical staging and 148 patients received radiotherapy . Women with locally advanced cervical cancer, no active treatment at survey, available telephone communication, and ability and willingness to provide verbal informed consent were considered to include in the current study.
  • primary endometrial cancer group patients with endometrial cancer who underwent surgery, no active treatment at survey, available telephone communication, and ability and willingness to provide verbal informed consent were considered to include in the current study

Treatment and study plan

Primary outcomes

  1. Gynecologic Cancer Lymphedema Questionnaire

    Time frame: The study outcome measure will be assessed by telephone interview , one time.

    There are no more follow up except one time telephone interview.

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Registry information

Official study title

The Cross-sectional and Questionnaire Study of Pelvic and Lower Extremity Lymphedema After Treatment of Gynecological Disease

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 24, 2014
Registry last updated
Feb 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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