Clinical trial NCT02069171: Cross-sectional and Questionnaire Study for Leg Lymphedema
Official title: The Cross-sectional and Questionnaire Study of Pelvic and Lower Extremity Lymphedema After Treatment of Gynecological Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gynecologic Cancer
Keywords: Lower extremity edema
Lower leg lymphedema
Lower leg edema
Lymphedema
Pelvic lymph node dissection
Gynecologic Cancer Lymphedema Questionnaire
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2014-02-24
Enrollment: 333
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the patient who gynecologic cancer treatment at National Cancer Center (2001\~2011)

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

Detailed description: 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.

Eligibility criteria: * Inclusion criteria

  1. the patient who gynecologic cancer treatment at National Cancer Center , Korea(2001\~2011)
  2. no active cancer treatment at the moment
  3. 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

Primary outcomes:
measure: Gynecologic Cancer Lymphedema Questionnaire
timeFrame: The study outcome measure will be assessed by telephone interview , one time.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Cancer Center, Korea
name: Myong Cheol Lim, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: