Cross-sectional and Questionnaire Study for Leg Lymphedema

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02069171

Enrollment

333

Registered

2014-02-24

Start date

2012-06-30

Completion date

2012-11-30

Last updated

2014-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecologic Cancer

Keywords

Lower extremity edema, Lower leg lymphedema, Lower leg edema, Lymphedema, Pelvic lymph node dissection, Gynecologic Cancer Lymphedema Questionnaire

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Gynecologic Cancer Lymphedema Questionnaire	The study outcome measure will be assessed by telephone interview , one time.	There are no more follow up except one time telephone interview.

Outcome results