An observational study in Lower Extremity Lymphedema and Endometrial Cancer, sponsored by Duke University. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-23.
Sponsored by Duke University · Observational
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.
1,325 studies on the registry are indexed under Endometrial Neoplasms; 447 are open to participants now.
This study's enrollment of 100 is below the median of 179 across 321 observational studies indexed under Endometrial Neoplasms.
Browse Endometrial Neoplasms studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
(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:
change in incidence of lower-extremity lymphedema
Time frame: 1 month, 6-9 months and 12-18 months after staging surgery for endometrial cancer
change in lymphedema-related morbidity
Time frame: 1 month 6-9 months and 12-18 months after staging surgery for endometrial cancer
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.
Time frame: pre-operatively, 1 month post-op, 6-9 months and 12-18 months post-op
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Duke University