Lymphedema in Endometrial Cancer

Completed

• Conditions: Endometrial Cancer; Lower Extremity Lymphedema

• Registration Number: NCT01914276
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-31
• Study First Submitted QC: 2013-08-01
• Study First Posted: 2013-08-02
• Study Start: 2013-10
• Status Verified: 2017-06
• Primary Completion: 2017-06
• Last Update Submitted: 2017-06-22
• Last Update Posted: 2017-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

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Exclusion Criteria

1. metastatic disease,
2. laparotomy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in incidence of lower-extremity lymphedema	1 month, 6-9 months and 12-18 months after staging surgery for endometrial cancer

Secondary Outcome Measures

Name	Time	Method
change in lymphedema-related morbidity	1 month 6-9 months and 12-18 months after staging surgery for endometrial cancer

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States