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NCT Number: NCT04839614

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).

Recruiting

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral

Other

See arm description

Primary outcomes

  1. 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

  2. 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).

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Post Operative 12-item Short Form Healthy Survey (SF-12) Survey

    Time frame: 6 months

    12-item Short Form Healthy Survey (SF-12) Survey

Study contacts

Contact information is provided by the study sponsor or research team.

Colleen Feltmate, MD

CONTACT

[email protected]

617-732-8840

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Important dates

Study start
2021
Primary completion
2027
Study completion
2028
First posted
Apr 9, 2021
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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