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

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).

Study Overview

• Status: Recruiting
• Conditions: Obesity; Endometrial Carcinoma; Endometrial Cancer Stage I; Endometrial Intraepithelial Neoplasia; EIN
• Intervention / Treatment: Other: CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral

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
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Colleen Feltmate, MD; Phone Number: 617-732-8840; Email: cfeltmate@bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Colleen Feltmate, MD
      • Principal Investigator: Colleen Feltmate, MD
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana-Farber Cancer Institute
      • Principal Investigator: Colleen Feltmate, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Other: CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral; See arm description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Colleen Feltmate, MD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: April 7, 2021
• First Submitted That Met QC Criteria: April 7, 2021
• First Posted (Actual): April 9, 2021

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Obesity; Endometrial Carcinoma; Bariatric Surgery; EIN; Endometrial Intraepithelial Neoplasia; Endometrial Cancer Stage I; Weight Loss Surgery
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Urogenital Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Body Weight; Body Weight Changes; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Neoplasms; Carcinoma in Situ; Carcinoma; Weight Loss; Endometrial Hyperplasia; Endometrial Neoplasms
• Other Study ID Numbers: 19-419

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No