Brief Title
Lymphedema in Endometrial Cancer
Official Title
A Pilot Study of Postoperative Lower-extremity Lymphedema and Quality of Life Among Women Undergoing Endometrial Cancer Staging Surgery
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.
Study Type
Observational
Primary Outcome
change in incidence of lower-extremity lymphedema
Secondary Outcome
change in lymphedema-related morbidity
Condition
Lower Extremity Lymphedema
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
100
Start Date
October 2013
Primary Completion Date
June 2017
Eligibility Criteria
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Laura Havrilesky, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01914276
Organization ID
Pro00047483
Responsible Party
Sponsor
Study Sponsor
Duke University
Study Sponsor
Laura Havrilesky, MD, Principal Investigator, Duke University
Verification Date
June 2017