CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral
OtherSee arm description
NCT Number: NCT04839614
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).
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Brigham and Women's Hospital, Boston, Massachusetts, United States
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
--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
Exclusion criteria
--This includes active smokers, prior bariatric surgery, active substance abuse, recent suicide attempt, bulimia nervosa, large abdominal hernias, or poorly controlled psychiatric illness
See arm description
Time frame: 2 Weeks
50% of the patients utilize the referral system and attend an initial consultation, it will be considered feasible
Time frame: 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).
Time frame: 3 weeks
compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population
Time frame: 3 weeks
compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population
Time frame: 1 Day
compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population
Time frame: 1 Day
compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population
Time frame: 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
Time frame: 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
Time frame: 6 months
12-item Short Form Healthy Survey (SF-12) Survey
Contact information is provided by the study sponsor or research team.
Dana-Farber Cancer Institute
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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