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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.
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| Measure | Description | Time Frame |
|---|---|---|
| change in incidence of lower-extremity lymphedema | 1 month, 6-9 months and 12-18 months after staging surgery for endometrial cancer |
| Measure | Description | Time Frame |
|---|---|---|
| change in lymphedema-related morbidity | 1 month 6-9 months and 12-18 months after staging surgery for endometrial cancer |
| Measure | Description | Time Frame |
|---|---|---|
| change in quality of life in women with endometrial cancer who undergo staging surgery | 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. |
Inclusion Criteria:
Exclusion Criteria:
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(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
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| Name | Affiliation | Role |
|---|---|---|
| Laura Havrilesky, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| pre-operatively, 1 month post-op, 6-9 months and 12-18 months post-op |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |