Brief Title
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
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).
Study Type
Interventional
Primary Outcome
proportion of patients who schedule an appointment and speak with a surgeon 1-2 weeks after enrollment
Secondary Outcome
Safety of the concurrent surgeries
Condition
Endometrial Carcinoma
Intervention
CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral
Study Arms / Comparison Groups
CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
30
Start Date
September 2021
Completion Date
June 30, 2024
Primary Completion Date
June 30, 2022
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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Colleen Feltmate, MD, 617-732-8840, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04839614
Organization ID
19-419
Responsible Party
Principal Investigator
Study Sponsor
Dana-Farber Cancer Institute
Study Sponsor
Colleen Feltmate, MD, Principal Investigator, Brigham and Women's Hospital
Verification Date
April 2021