Lymphedema in Endometrial Cancer

NCT01914276 | Completed

• 1 other identifier: Pro00047483
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Extremity Lymphedema; Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

• change in incidence of lower-extremity lymphedema

  1 month, 6-9 months and 12-18 months after staging surgery for endometrial cancer

Secondary Outcomes (1)

• change in lymphedema-related morbidity

  1 month 6-9 months and 12-18 months after staging surgery for endometrial cancer

Other Outcomes (1)

• change in quality of life in women with endometrial cancer who undergo staging surgery

  pre-operatively, 1 month post-op, 6-9 months and 12-18 months post-op

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

(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

You may qualify if:

• women older than 18 years old,
• endometrial cancer,
• suitable candidates for surgery,
• scheduled to undergo laparoscopy or robotic-assisted (RA) laparoscopy for endometrial cancer at Duke University Medical Center (DUMC),
• no severe physical or mental comorbidity

You may not qualify if:

• metastatic disease,
• laparotomy

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Laura Havrilesky, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2013
• First Posted: August 2, 2013
• Study Start: October 1, 2013
• Primary Completion: June 1, 2017
• Last Updated: June 23, 2017

Record last verified: 2017-06

Locations

US (1)