RecruitingNot ApplicableNCT04839614

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


Sponsor

Dana-Farber Cancer Institute

Enrollment

30 participants

Start Date

Aug 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining weight-loss surgery with a laparoscopic hysterectomy (womb removal) in a single operation is safe and effective for obese women with early-stage uterine cancer or a pre-cancerous condition of the uterine lining. **You may be eligible if:** - You are a woman aged 18 or older - You have a BMI of 35–39.9 with at least one serious weight-related health condition (such as type 2 diabetes, sleep apnea, high blood pressure, or others), OR a BMI of 40 or above - You have been diagnosed with low-grade (grade 1) uterine cancer or uterine precancer (endometrial intraepithelial neoplasia) confirmed by biopsy **You may NOT be eligible if:** - Your uterine cancer is grade 2 or higher - You are pregnant - You have conditions that make bariatric (weight-loss) surgery unsafe, such as active smoking, a history of prior bariatric surgery, severe psychiatric illness, or eating disorders like bulimia Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERCONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral

See arm description


Locations(2)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

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NCT04839614


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