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

ENROLLING
Protocol # :
19-419
Conditions
Endometrial Carcinoma
Obesity
EIN
Endometrial Intraepithelial Neoplasia
Endometrial Cancer Stage I
Phase
Feasibility / Pilot
Disease Sites
Corpus Uteri
Principal Investigator
Feltmate, Colleen, M.

Trial Description

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 Requirements

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.

19-419