Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT04839614

Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia

Led by Dana-Farber Cancer Institute · Updated on 2025-08-07

30

Participants Needed

2

Research Sites

360 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

To assess the feasibility of an expedited referral process for the obese endometrial cancer or EIN patient from her gynecologic oncologist to the Brigham Center for Metabolic and Bariatric Surgery (CMBS) in order to undergo concurrent weight loss surgery and hysterectomy within 8 weeks of first appointment with a gynecologic oncologist (or 12 weeks for EIN patients).

CONDITIONS

Official Title

Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female adults at least 18 years of age
  • A BMI of 35-39.99 with one or more severe obesity-related conditions such as type 2 diabetes, hypertension, hyperlipidemia, obstructive sleep apnea, obesity-hypoventilation syndrome, Pickwickian syndrome, nonalcoholic fatty liver disease or steatohepatitis, pseudotumor cerebri, gastroesophageal reflux disease, asthma, venous stasis disease, severe urinary incontinence, debilitating arthritis, or significantly impaired quality of life, OR a BMI of 40 or higher
  • Tissue diagnosis (usually from endometrial biopsy) of grade 1 endometrial carcinoma or endometrial intraepithelial neoplasia (EIN)
Not Eligible

You will not qualify if you...

  • Younger than 18 years old
  • BMI less than 35
  • No tissue diagnosis or diagnosis of grade 2 or higher endometrial cancer
  • Pregnancy
  • Contraindications to bariatric surgery, including active smoking, prior bariatric surgery, active substance abuse, recent suicide attempt, bulimia nervosa, large abdominal hernias, or poorly controlled psychiatric illness
  • Inability to read English consent form or unwillingness to provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

2

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

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Research Team

C

Colleen Feltmate, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

1

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Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia | DecenTrialz