Brief Title
Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma/Intraepithelial Neoplasia
Official Title
Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia
Brief 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.
Detailed 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.
Study Type
Observational
Primary Outcome
The referral completion rate for the obese endometrial cancer or EIN patient from her gynecologic oncologist to the Brigham Center for Weight Management and Metabolic Surgery.
Secondary Outcome
Change in baseline systolic and diastolic pressures
Condition
Endometrial Cancer
Intervention
Referral to Center for Metabolic and Bariatric Surgery
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
20
Start Date
September 1, 2020
Completion Date
September 1, 2023
Primary Completion Date
September 1, 2022
Eligibility Criteria
Inclusion Criteria:
- 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.
- AND a tissue diagnosis (usually endometrial biopsy) of grade 1 endometrial carcinoma
or EIN.
Exclusion Criteria:
- Less than 18 years old
- BMI < 35
- no tissue diagnosis of EIN or grade 1 endometrial carcinoma
- a grade 2 or greater endometrial cancer tissue diagnosis.
- active smokers
- prior bariatric surgery
- active substance abuse
- recent suicide attempt
- bulimia nervosa
- poorly controlled psychiatric illness
- inability to read an English informed consent form
- unwillingness to provide informed consent
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Colleen M Feltmate, MD, 3055888569, [email protected]
Administrative Informations
NCT ID
NCT04278183
Organization ID
DFHCC19419
Responsible Party
Principal Investigator
Study Sponsor
Brigham and Women's Hospital
Collaborators
Dana-Farber Cancer Institute
Study Sponsor
Colleen M Feltmate, MD, Principal Investigator, Brigham and Women's Hospital
Verification Date
July 2020