Lymphedema in Endometrial Cancer

Endometrial Cancer Clinical Trial

Official title:

A Pilot Study of Postoperative Lower-extremity Lymphedema and Quality of Life Among Women Undergoing Endometrial Cancer Staging Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01914276
• Other study ID #: Pro00047483
• Status: Completed
• Phase: N/A
• First received: July 31, 2013
• Last updated: June 22, 2017
• Start date: October 2013

Study information

• Verified date: June 2017
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms
• Lower Extremity Lymphedema
• Lymphedema

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	pre-operatively, 1 month post-op, 6-9 months and 12-18 months post-op
Primary	change in incidence of lower-extremity lymphedema		1 month, 6-9 months and 12-18 months after staging surgery for endometrial cancer
Secondary	change in lymphedema-related morbidity		1 month 6-9 months and 12-18 months after staging surgery for endometrial cancer