Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma/Intraepithelial Neoplasia — WLS-TLH  

Obesity Clinical Trial

Official title: Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia

Status Not yet recruiting

Clinical Trial Summary

In the United States, the most significant risk factors for endometrial cancer (and EIN) are obesity and metabolic syndrome, given their high prevalence in this population. Given the high survival rate in early stage endometrial cancer, these patients, specifically those that are obese and have metabolic syndrome, are more likely to die of other causes. By treating an obese patient's endometrial cancer, one cause of death may be prevented but an important opportunity is missed to improve overall survival after cancer treatment. Concurrent laparoscopic hysterectomy and weight loss surgery is not an experimental procedure. This combined procedure has successfully been performed at our institution numerous times but there is a lack of data describing clinical outcomes and ideal patient selection. The goal of this study is 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 Weight Management and Metabolic Surgery. Secondary outcomes will include short-term and long-term obesity-related outcomes (i.e., better diabetes control, lowered cholesterol, lowered baseline blood pressure) as well as whether quality of life is improved post-operatively compared to preoperatively in concurrent surgery.

Clinical Trial Description

A total of 20 patients will be enrolled for this feasibility study. Included in this study will be female adults at least 18 years of age with

1. A BMI of 35-39.99 and 1 or more severe obesity-related co-morbidities (including T2D, hypertension, hyperlipidemia, obstructive sleep apnea (OSA), obesity-hypoventilation syndrome (OHS), Pickwickian syndrome (a combination of OSA and OHS), nonalcoholic 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.

2. AND a tissue diagnosis (usually endometrial biopsy) of endometrial carcinoma or EIN.

Excluded in this study will be patients younger than 18 years old, with a BMI < 35, those without a tissue diagnosis, or with a grade 2 or greater endometrial cancer tissue diagnosis. 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, or poorly controlled psychiatric illness. Exclusion criteria will also include inability to read an English informed consent form, and unwillingness to provide informed consent.

Appropriate candidates will be selected from the outpatient clinic schedule of gynecologic oncologists at BWH as well as the satellite offices where gynecologic oncologists see patients. Before enrollment, an attending gynecologic oncologist, who is known to the potential subject and has first-hand knowledge of the patient's medical history must (1) initially introduce the study to the patient AND (2) obtain the patient's consent AND (3) give approval for his/her patient to be contacted for research purposes. The surgeons will use the following standardized prompt, "Have you ever considered surgery to address your weight?" to recruit patients. If the patient answers in the affirmative, then the study protocol will be presented to them using a standardized script to ensure all discussion points are discussed.

After informed consent is signed, the subject will be referred to the Brigham Center for Weight Management and Metabolic Surgery. The co-investigators on this study have discussed expedited patient referrals to the Brigham Center for Weight Management and Metabolic Surgery in the interest of not delaying their surgery for endometrial cancer or EIN. Both patients that successfully undergo concurrent laparoscopic hysterectomy and weight loss surgery as well as any other patients that receive a referral to a bariatric surgeon will be included in this study. If it becomes apparent that the concurrent surgery cannot be scheduled within 8 weeks of the initial visit with her gynecologic oncologist, then the patient will proceed with hysterectomy alone. Though there is no literature on survival outcomes based on time to curative surgery in EIN patients, it is presumed that women might be able to wait slightly longer for their combined surgery. For that reason, the cutoff for time to surgery in EIN patients will be 10 weeks.

Patients must see the bariatric surgeon within 1-2 weeks as the concurrent surgery must be performed within 8 weeks (or 10 weeks for EIN) of the patient's initial visit with the gynecologic oncologist. If patients are deemed eligible for WLS, patients will be scheduled immediately for a nutrition consultation and psychologic evaluation at the Brigham and Women's Center for Metabolic and Bariatric Surgery (CMBS). CMBS will simultaneously help patients undergo the process of obtaining insurance approval for concurrent procedure. Once approved by CBMS staff as well as their insurance provider, patient will be scheduled for laparoscopic hysterectomy and WLS. The concurrent surgeries will be performed in the same manner the procedures have been performed in the past.

Their post-operative appointments with each surgeon will be coordinated, to the best of the study staff's ability, on the same day within a 2-3 week post-operative period. Per NCCN surveillance guidelines, patients with endometrial cancer will also be seen again by the gynecologic oncologist at 6 months and 1 year before transferring care back to their primary gynecologist for pelvic exams q6 months for 2-3 and then annually [16]. EIN patients will only have to be seen at their 2 week post-operative follow up visit. All subjects will also follow up at the CMBS per standard protocol.

All of the variables required for this study will be collected as part of clinical care. It is anticipated all data is available in the EMR. The investigators will obtain demographic data such as age, race, and sex. The investigators will also collect clinical data such as medications, past medical history, and lab details. Details of the operation and post-operative laboratory data will be abstracted from clinical records and entered it into the electronic database. Data collected will include: patient's demographics, co-morbidities and baseline lab values (i.e., Hgb A1c, lipid panel); timing of the referral process, insurance barriers, intraoperative data (i.e., anesthesia time, length of case, complications, etc.), post-operative data (length of inpatient stay, weight changes, follow up compliance, etc.); quality of life survey (Short Form Healthy Survey) responses pre- and post-operatively. ;

Related Conditions & MeSH terms

• Carcinoma in Situ
• Endometrial Cancer
• Endometrial Intraepithelial Neoplasia
• Endometrial Neoplasms
• Neoplasms
• Obesity
• Weight Loss

• NCT number: NCT04278183
• Study type: Observational
• Source: Brigham and Women's Hospital
• Contact: Alexandra S Bercow, MD
• Phone: 3055888569
• Email: abercow@partners.org
• Status: Not yet recruiting
• Start date: May 1, 2021
• Completion date: June 1, 2024