Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma/Intraepithelial Neoplasia

Obesity Clinical Trial

— WLS-TLH  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04278183
• Other study ID #: DFHCC19419
• Status: Not yet recruiting
• Start date: May 1, 2021
• Est. completion date: June 1, 2024

Study information

• Verified date: February 2021
• Source: Brigham and Women's Hospital
• Contact: Alexandra S Bercow, MD
• Phone: 3055888569
• Email: abercow[@]partners.org
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Referral to Center for Metabolic and Bariatric Surgery
Gynecologic oncologists will refer patients to bariatric surgeons at the weight loss center.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Dana-Farber Cancer Institute

References & Publications (10)

Calle EE, Rodriguez C, Walker-Thurmond K, Thun MJ. Overweight, obesity, and mortality from cancer in a prospectively studied cohort of U.S. adults. N Engl J Med. 2003 Apr 24;348(17):1625-38. — View Citation

Elit LM, O'Leary EM, Pond GR, Seow HY. Impact of wait times on survival for women with uterine cancer. J Clin Oncol. 2014 Jan 1;32(1):27-33. doi: 10.1200/JCO.2013.51.3671. Epub 2013 Nov 25. — View Citation

Jernigan AM, Maurer KA, Cooper K, Schauer PR, Rose PG, Michener CM. Referring survivors of endometrial cancer and complex atypical hyperplasia to bariatric specialists: a prospective cohort study. Am J Obstet Gynecol. 2015 Sep;213(3):350.e1-10. doi: 10.1016/j.ajog.2015.05.015. Epub 2015 May 14. — View Citation

Matsuo K, Moeini A, Cahoon SS, Machida H, Ciccone MA, Grubbs BH, Muderspach LI. Weight Change Pattern and Survival Outcome of Women with Endometrial Cancer. Ann Surg Oncol. 2016 Sep;23(9):2988-97. doi: 10.1245/s10434-016-5237-9. Epub 2016 Apr 25. — View Citation

Mechanick JI, Youdim A, Jones DB, Garvey WT, Hurley DL, McMahon MM, Heinberg LJ, Kushner R, Adams TD, Shikora S, Dixon JB, Brethauer S; American Association of Clinical Endocrinologists; Obesity Society; American Society for Metabolic & Bariatric Surgery. Clinical practice guidelines for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient--2013 update: cosponsored by American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery. Obesity (Silver Spring). 2013 Mar;21 Suppl 1:S1-27. doi: 10.1002/oby.20461. — View Citation

Nevadunsky NS, Van Arsdale A, Strickler HD, Moadel A, Kaur G, Levitt J, Girda E, Goldfinger M, Goldberg GL, Einstein MH. Obesity and age at diagnosis of endometrial cancer. Obstet Gynecol. 2014 Aug;124(2 Pt 1):300-306. doi: 10.1097/AOG.0000000000000381. — View Citation

Rakha E, Wong SC, Soomro I, Chaudry Z, Sharma A, Deen S, Chan S, Abu J, Nunns D, Williamson K, McGregor A, Hammond R, Brown L. Clinical outcome of atypical endometrial hyperplasia diagnosed on an endometrial biopsy: institutional experience and review of literature. Am J Surg Pathol. 2012 Nov;36(11):1683-90. doi: 10.1097/PAS.0b013e31825dd4ff. Review. — View Citation

Shalowitz DI, Epstein AJ, Buckingham L, Ko EM, Giuntoli RL 2nd. Survival implications of time to surgical treatment of endometrial cancers. Am J Obstet Gynecol. 2017 Mar;216(3):268.e1-268.e18. doi: 10.1016/j.ajog.2016.11.1050. Epub 2016 Dec 9. — View Citation

Strohl AE, Feinglass JM, Shahabi S, Simon MA. Surgical wait time: A new health indicator in women with endometrial cancer. Gynecol Oncol. 2016 Jun;141(3):511-515. doi: 10.1016/j.ygyno.2016.04.014. Epub 2016 Apr 23. — View Citation

Ward KK, Shah NR, Saenz CC, McHale MT, Alvarez EA, Plaxe SC. Cardiovascular disease is the leading cause of death among endometrial cancer patients. Gynecol Oncol. 2012 Aug;126(2):176-9. doi: 10.1016/j.ygyno.2012.04.013. Epub 2012 Apr 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The referral completion rate will be defined as the number of patients who verbally accept a referral to the weight loss center from her gynecologic oncologist that actually attend an appointment with a bariatric surgeon divided by the number of patients who verbally accepted a referral.	The time frame will be however long it takes to recruit a total of 20 patients. This is anticipated to be 1-2 years.
Primary	The referral acceptance rate for the obese endometrial cancer or EIN patient from her gynecologic oncologist to the Brigham Center for Weight Management and Metabolic Surgery.	The referral acceptance rate will be defined as the number of patients who verbally accept a referral to the weight loss center from her gynecologic oncologist, regardless of whether they attend an appointment with a bariatric surgeon, divided by the number of patients offered a referral.	The time frame will be however long it takes to recruit a total of 20 patients. This is anticipated to be 1-2 years.
Primary	The surgical completion rate of concurrent laparoscopic hysterectomy and weight loss surgery in obese patients with endometrial carcinoma or EIN who are referred to the weight loss center at their initial visit with a gynecologic oncologist.	The surgical completion rate will be defined as the number of subjects who undergo concurrent laparoscopic hysterectomy and weight loss surgery divided by the number of subjects enrolled in the study.	The time frame will be however long it takes to recruit a total of 20 patients. This is anticipated to be 1-2 years.
Secondary	Change in baseline systolic and diastolic pressures	Difference between pre-operative and post-operative systolic and diastolic pressures in patients who undergo concurrent hysterectomy and weight loss surgery. This will be measured by the difference in their pre-op and post-op visit at the weight loss center.	1 year of postoperative follow up
Secondary	Change in BMI	Difference between pre-operative and post-operative BMI in patients who undergo concurrent hysterectomy and weight loss surgery. This will be measured by the difference in their pre-op and post-op visit at the weight loss center. Weight and height will be combined to report BMI in kg/m^2.	1 year of postoperative follow up
Secondary	Change in hemoglobin A1c	Difference between pre-operative and post-operative Hgb A1c in patients who undergo concurrent hysterectomy and weight loss surgery. This will be measured by the difference in their pre-op and post-op visit at the weight loss center.	1 year of postoperative follow up
Secondary	Change in LDL	Difference between pre-operative and post-operative LDL in patients who undergo concurrent hysterectomy and weight loss surgery. This will be measured by the difference in their pre-op and post-op visit at the weight loss center.	1 year of postoperative follow up
Secondary	Change in HDL	Difference between pre-operative and post-operative HDL in patients who undergo concurrent hysterectomy and weight loss surgery. This will be measured by the difference in their pre-op and post-op visit at the weight loss center.	1 year of postoperative follow up
Secondary	Change in Short Form Healthy Survey score	Difference between pre-operative and post-operative Short Form Healthy Survey Score in patients who undergo concurrent hysterectomy and weight loss surgery. Higher scores signify a better outcome, or better quality of life, so a positive value for a change in score is considered better quality of life. The minimum value is 0 and the maximum value is 100.	1 year of postoperative follow up.