Clinical trial NCT04839614: Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia
Official title: Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometrial Carcinoma
Obesity
EIN
Endometrial Intraepithelial Neoplasia
Endometrial Cancer Stage I
Keywords: Endometrial Carcinoma
Obesity
EIN
Endometrial Intraepithelial Neoplasia
Endometrial Cancer Stage I
Weight Loss Surgery
Bariatric Surgery
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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 (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).

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 to their weight, like heart disease, stroke, and diabetes. Weight loss surgery has been shown to help patients lose weight and also decrease their risk for obesity-related diseases.

This research study is a Feasibility Study. This is the first-time investigators are studying both 1) the referral process of patients with endometrial cancer to the Center for Metabolic and Bariatric Surgery without delaying curative treatment of endometrial cancer 2) the combined surgery of both hysterectomy and weight loss surgery. The combined surgery of hysterectomy and weight loss surgery has been performed both at this institution and others without increased complications, but it has not been formally studied.

Approximately 30 patients are expected to participate in this study at Brigham and Women's Hospital (BWH).

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.

Primary outcomes:
measure: proportion of patients who schedule an appointment and speak with a surgeon 1-2 weeks after enrollment
timeFrame: 2 Weeks
measure: proportion of patients who undergo the concurrent surgeries within 8 weeks of diagnosis (12 weeks for EIN patients)
timeFrame: up 12 weeks
Secondary outcomes:
measure: Safety of the concurrent surgeries
timeFrame: 3 weeks
measure: Postoperative complications
timeFrame: 3 weeks
measure: Time under anesthesia
timeFrame: 1 Day
measure: Total time in operating room
timeFrame: 1 Day
measure: Postoperative weight loss
timeFrame: 6 months, 1 year
measure: Changes in lab values reflecting comorbid conditions
timeFrame: 6 months, 1 year
measure: Post Operative 12-item Short Form Healthy Survey (SF-12) Survey
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Colleen Feltmate, MD
role: PRINCIPAL_INVESTIGATOR
References: