A Pilot Study of Postoperative Lower-extremity Lymphedema and Quality of Life Among Women Undergoing Endometrial Cancer Staging Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lower Extremity Lymphedema
- Sponsor
- Duke University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- change in incidence of lower-extremity lymphedema
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
Objectives: (1) To determine the incidence of lower-extremity lymphedema after staging surgery for endometrial cancer; (2) to describe lymphedema-related morbidity after staging surgery for endometrial cancer and (3) to evaluate pre- and post-operative quality of life in women with endometrial cancer who undergo staging surgery.
Data analysis and risk/safety issues: The proposed study will consist of a convenience sample of women who undergo minimally invasive surgery for endometrial cancer over a 1 year period. The investigators anticipate enrollment of 75 to 100 women. Frequency tables and difference with its 95% exact confidence intervals between pre-and post-operative lower extremity lymphedema measurements and quality of life questionnaires will be estimated.
Investigators
Eligibility Criteria
Inclusion Criteria
- •women older than 18 years old,
- •endometrial cancer,
- •suitable candidates for surgery,
- •scheduled to undergo laparoscopy or robotic-assisted (RA) laparoscopy for endometrial cancer at Duke University Medical Center (DUMC),
- •no severe physical or mental comorbidity
Exclusion Criteria
- •metastatic disease,
Outcomes
Primary Outcomes
change in incidence of lower-extremity lymphedema
Time Frame: 1 month, 6-9 months and 12-18 months after staging surgery for endometrial cancer
Secondary Outcomes
- change in lymphedema-related morbidity(1 month 6-9 months and 12-18 months after staging surgery for endometrial cancer)