EIN, Endometrial Cancer Stage I, Endometrial Carcinoma, Endometrial Intraepithelial Neoplasia, Obesity
Conditions
Keywords
Endometrial Carcinoma, Obesity, EIN, Endometrial Intraepithelial Neoplasia, Endometrial Cancer Stage I, Weight Loss Surgery, Bariatric Surgery
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).
Interventions
OTHERCONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral
See arm description
Sponsors
Dana-Farber Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Postoperative complications | 3 weeks | compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population |
| 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 |
| 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 |
| 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 |
| 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 |
| Post Operative 12-item Short Form Healthy Survey (SF-12) Survey | 6 months | 12-item Short Form Healthy Survey (SF-12) Survey |
Countries
United States
Contacts
CONTACTColleen Feltmate, MD
PRINCIPAL_INVESTIGATORColleen Feltmate, MD
Brigham and Women's Hospital
Outcome results
None listed