Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia
- Conditions
- ObesityEndometrial Intraepithelial NeoplasiaEndometrial Cancer Stage IEndometrial CarcinomaEIN
- Interventions
- Other: CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral
- Registration Number
- NCT04839614
- Lead Sponsor
- Dana-Farber Cancer Institute
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 30
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Female adults at least 18 years of age
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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
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Tissue diagnosis (usually endometrial biopsy) of grade 1 endometrial carcinoma or EIN.
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Younger than 18 years old
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BMI < 35
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Without a tissue diagnosis, or with a grade 2 or greater endometrial cancer tissue diagnosis
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Pregnant participants will be excluded from this study.
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral 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.
- Primary Outcome Measures
Name Time Method proportion of patients who schedule an appointment and speak with a surgeon 1-2 weeks after enrollment 2 Weeks 50% of the patients utilize the referral system and attend an initial consultation, it will be considered feasible
proportion of patients who undergo the concurrent surgeries within 8 weeks of diagnosis (12 weeks for EIN patients) up 12 weeks concurrent surgery will be considered feasible if 50% (7-8 patients) of patients who undergo an initial consultation at the CMBS actually undergo concurrent surgery within 8 weeks of diagnosis (or 12 weeks for EIN).
- Secondary Outcome Measures
Name Time Method Time under anesthesia 1 Day compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population
Postoperative complications 3 weeks compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population
Postoperative weight loss 6 months, 1 year Paired t-test or Wilcoxon rank sum test will be used to compare pre- and post-surgical outcomes and survey responses
Safety of the concurrent surgeries 3 weeks compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population
Post Operative 12-item Short Form Healthy Survey (SF-12) Survey 6 months 12-item Short Form Healthy Survey (SF-12) Survey
Total time in operating room 1 Day compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population
Changes in lab values reflecting comorbid conditions 6 months, 1 year Paired t-test or Wilcoxon rank sum test will be used to compare pre- and post-surgical outcomes and survey responses
Trial Locations
- Locations (2)
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States