Status:
RECRUITING
Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia
Lead Sponsor:
Dana-Farber Cancer Institute
Conditions:
Endometrial Carcinoma
Obesity
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 (CM...
Detailed Description
The most common risk factor for endometrial cancer is obesity. However, because early-stage endometrial cancer has a very high survival rate, patients more often suffer from long-term issues related t...
Eligibility Criteria
Inclusion
- Female adults at least 18 years of age
- A BMI of 35-39.99 and 1 or more severe obesity-related co-morbidities
- -including T2D,112 hypertension, hyperlipidemia, obstructive sleep apnea (OSA), obesity-hypoventilation syndrome (OHS), Pickwickian syndrome (a combination of OSA and OHS), nonalcoholic 4 fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH), pseudotumor cerebri, gastroesophageal reflux disease (GERD), asthma, venous stasis disease, severe urinary incontinence, debilitating arthritis, or considerably impaired quality of life) OR a BMI ≥ 40
- Tissue diagnosis (usually endometrial biopsy) of grade 1 endometrial carcinoma or EIN.
Exclusion
- Younger than 18 years old
- BMI \< 35
- Without a tissue diagnosis, or with a grade 2 or greater endometrial cancer tissue diagnosis
- Pregnant participants will be excluded from this study.
- Patients with contraindications to bariatric surgery will also be excluded.
- -This includes active smokers, prior bariatric surgery, active substance abuse, recent suicide attempt, bulimia nervosa, large abdominal hernias, or poorly controlled psychiatric illness
- include inability to read an English informed consent form, and unwillingness to provide informed consent.
Key Trial Info
Start Date :
August 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04839614
Start Date
August 1 2021
End Date
June 30 2028
Last Update
August 7 2025
Active Locations (2)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215