Endometrial Cancer, Lower Extremity Lymphedema
Conditions
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.
Interventions
None listed
Sponsors
Duke University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. women older than 18 years old, 2. endometrial cancer, 3. suitable candidates for surgery, 4. scheduled to undergo laparoscopy or robotic-assisted (RA) laparoscopy for endometrial cancer at Duke University Medical Center (DUMC), 5. no severe physical or mental comorbidity
Exclusion criteria
1. metastatic disease, 2. laparotomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in incidence of lower-extremity lymphedema | 1 month, 6-9 months and 12-18 months after staging surgery for endometrial cancer |
Secondary
| Measure | Time frame |
|---|---|
| change in lymphedema-related morbidity | 1 month 6-9 months and 12-18 months after staging surgery for endometrial cancer |
Other
| Measure | Time frame | Description |
|---|---|---|
| change in quality of life in women with endometrial cancer who undergo staging surgery | pre-operatively, 1 month post-op, 6-9 months and 12-18 months post-op | The study team plans to measure QoL via 2 questionnaires, specifically the EQ-5D and FACT-G. FACT-G and EQ-5D-derived utility scores will be calculated and summarized pre- and post-operatively for all patients using descriptive statistics (means, medians, ranges). The difference with 95% exact confidence intervals between pre- and post-operative FACT-G scores and EQ-5D utility scores obtained at each post-operative visit (t1, t2, & t3) will be estimated. |
Countries
United States
Outcome results
None listed