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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY | Experimental | Upon enrollment in the study at first appointment with gynecologic oncologist, referral to the BWH Center for Metabolic and Bariatric Surgery (CMBS).
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral | Other | See arm description |
|
| Measure | Description | Time Frame |
|---|---|---|
| proportion of patients who schedule an appointment and speak with a surgeon 1-2 weeks after enrollment | 50% of the patients utilize the referral system and attend an initial consultation, it will be considered feasible | 2 Weeks |
| proportion of patients who undergo the concurrent surgeries within 8 weeks of diagnosis (12 weeks for EIN patients) | 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). | up 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the concurrent surgeries | compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population | 3 weeks |
| Postoperative complications |
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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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Colleen Feltmate, MD | Contact | 617-732-8840 | cfeltmate@bwh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Colleen Feltmate, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Data can be shared no earlier than 1 year following the date of publication
Contact the Partners Innovations team at http://www.partners.org/innovation
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compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population
| 3 weeks |
| Time under anesthesia | compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population | 1 Day |
| Total time in operating room | compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population | 1 Day |
| Postoperative weight loss | Paired t-test or Wilcoxon rank sum test will be used to compare pre- and post-surgical outcomes and survey responses | 6 months, 1 year |
| Changes in lab values reflecting comorbid conditions | Paired t-test or Wilcoxon rank sum test will be used to compare pre- and post-surgical outcomes and survey responses | 6 months, 1 year |
| Post Operative 12-item Short Form Healthy Survey (SF-12) Survey | 12-item Short Form Healthy Survey (SF-12) Survey | 6 months |
| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
|
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D009765 | Obesity |
| D004714 | Endometrial Hyperplasia |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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