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

Last updated: July 15, 2024
Sponsor: Dana-Farber Cancer Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Endometrial Hyperplasia

Weight Loss

Diabetes Prevention

Treatment

CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral

Clinical Study ID

NCT04839614
19-419
  • Ages > 18
  • Female

Study 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).

Eligibility Criteria

Inclusion

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 OSAand OHS), nonalcoholic 4 fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH), pseudotumor cerebri, gastroesophageal reflux disease (GERD), asthma, venousstasis disease, severe urinary incontinence, debilitating arthritis, or considerablyimpaired quality of life) OR a BMI ≥ 40

  • Tissue diagnosis (usually endometrial biopsy) of grade 1 endometrial carcinoma orEIN.

Exclusion

Exclusion Criteria:

  • Younger than 18 years old

  • BMI < 35

  • Without a tissue diagnosis, or with a grade 2 or greater endometrial cancer tissuediagnosis

  • 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 poorlycontrolled psychiatric illness

  • include inability to read an English informed consent form, and unwillingness toprovide informed consent.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral
Phase:
Study Start date:
August 01, 2021
Estimated Completion Date:
June 30, 2026

Study 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).

Connect with a study center

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.