Skip to main content
OpenTrials
Completed

NCT Number: NCT01914276

Lymphedema in Endometrial Cancer

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lower Extremity Lymphedema Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • metastatic disease,
  • laparotomy

Treatment and study plan

Primary outcomes

  1. change in incidence of lower-extremity lymphedema

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

Secondary outcomes

  1. change in lymphedema-related morbidity

    Time frame: 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

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

    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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
First posted
Aug 2, 2013
Registry last updated
Jun 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.