Cross-sectional and Questionnaire Study for Leg Lymphedema

National Cancer Center (NCC)

Status: Completed

Conditions: Gynecologic Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT02069171

NCCNCS-12-565 (Other Grant/Funding Number)

NCC_GO_2012_01_2

Details and patient eligibility

About

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

Full 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.

Enrollment: 333 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

333 participants in 3 patient groups

early ovarian cancer group

locally advanced cervical cancer group

primary endometrial cancer group