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

• ClinicalTrials.gov Identifier: NCT04839614
• Recruitment Status: Recruiting
• First Posted: April 9, 2021
• Last Update Posted: July 27, 2023
• Sponsor: Dana-Farber Cancer Institute
• Information provided by (Responsible Party): Colleen Feltmate, MD, Brigham and Women's Hospital

Tracking Information

• First Submitted Date: April 7, 2021
• First Posted Date: April 9, 2021
• Last Update Posted Date: July 27, 2023
• Actual Study Start Date: August 1, 2021
• Estimated Primary Completion Date: June 30, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 7, 2021)

• proportion of patients who schedule an appointment and speak with a surgeon 1-2 weeks after enrollment [ Time Frame: 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) [ Time Frame: 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).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 7, 2021)

• Safety of the concurrent surgeries [ Time Frame: 3 weeks ]
  compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population
• Postoperative complications [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 months ]
  12-item Short Form Healthy Survey (SF-12) Survey

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia
• Official Title: Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia
• 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).

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research

Condition

• Endometrial Carcinoma
• Obesity
• EIN
• Endometrial Intraepithelial Neoplasia
• Endometrial Cancer Stage I

Intervention

Other: CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral

See arm description

Study Arms

Experimental: CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY

Upon enrollment in the study at first appointment with gynecologic oncologist, referral to the BWH Center for Metabolic and Bariatric Surgery (CMBS).

• Schedule a series of appointments with a bariatric surgeon, nutritionist and psychologist, which is part of the approval process for weight loss surgery.
• Hysterectomy and weight loss surgery will then be scheduled on the same day within 8 weeks from first visit with the gynecologic oncologist for endometrial cancer or 12 weeks if you have endometrial pre-cancer.
• Series of post-operative visits with the bariatric surgeon and gynecologic oncologic surgeon as well as the nutritionist and psychologist.

Intervention: Other: CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 7, 2021): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 30, 2025
• Estimated Primary Completion Date: June 30, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Colleen Feltmate, MD; 617-732-8840; cfeltmate@bwh.harvard.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04839614
• Other Study ID Numbers: 19-419
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: 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.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

• Current Responsible Party: Colleen Feltmate, MD, Brigham and Women's Hospital
• Original Responsible Party: Colleen Feltmate, Brigham and Women's Hospital, Principal Investigator
• Current Study Sponsor: Dana-Farber Cancer Institute
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Colleen Feltmate, MD; Brigham and Women's Hospital

• PRS Account: Dana-Farber Cancer Institute
• Verification Date: July 2023