Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia
Endometrial Carcinoma, Obesity, EIN
About this trial
This is an interventional health services research trial for Endometrial Carcinoma focused on measuring Endometrial Carcinoma, Obesity, EIN, Endometrial Intraepithelial Neoplasia, Endometrial Cancer Stage I, Weight Loss Surgery, Bariatric Surgery
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Brigham and Women's HospitalRecruiting
- Dana-Farber Cancer InstituteRecruiting
Arms of the Study
Arm 1
Experimental
CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY
Upon enrollment in the study at first appointment with gynecologic oncologist, referral to the BWH Center for Metabolic and Bariatric Surgery (CMBS). Schedule a series of appointments with a bariatric surgeon, nutritionist and psychologist, which is part of the approval process for weight loss surgery. Hysterectomy and weight loss surgery will then be scheduled on the same day within 8 weeks from first visit with the gynecologic oncologist for endometrial cancer or 12 weeks if you have endometrial pre-cancer. Series of post-operative visits with the bariatric surgeon and gynecologic oncologic surgeon as well as the nutritionist and psychologist.