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

Obesity Endometrial Carcinoma Endometrial Intraepithelial Neoplasia Endometrial Cancer Stage I EIN

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

Inclusion Criteria4

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 Criteria7

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.