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Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery for Endometrial Cancer

This study is looking at whether it's practical to quickly refer obese women with endometrial cancer or a pre-cancerous condition called endometrial intraepithelial neoplasia (EIN) for two surgeries at the same time: a laparoscopic hysterectomy (removal of the uterus using small cuts) and weight loss surgery. The goal is to see if these surgeries can be done together without delaying the cancer treatment. You might be able to join if you are an adult woman, at least 18 years old, with a BMI between 35 and 39.99, and have at least one obesity-related health problem like type 2 diabetes or high blood pressure. The study will consider it a success if a good number of patients schedule an appointment with a surgeon soon after joining, and if they have both surgeries within 8 weeks of diagnosis (or 12 weeks for EIN patients). The current status of this study is unclear.

Study design
This is a feasibility study, meaning it's the first time these combined procedures and referral process are being formally studied. Approximately 30 patients are expected to participate.
What's involved
You would undergo concurrent laparoscopic hysterectomy and weight loss surgery. The study aims for these surgeries to occur within 8 weeks of diagnosis (or 12 weeks for EIN patients).
Compensation
Not stated in the trial record.
Follow-up
The study measures outcomes up to 12 weeks after enrollment, focusing on the timing of appointments and surgeries.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04839614

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

Recruiting
NAAges 18+InterventionalHealth services
Dana-Farber Cancer Institute
~30 participants
Updated 2025-08-07 on ClinicalTrials.gov
What's tested:CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
proportion of patients who schedule an appointment and speak with a surgeon 1-2 weeks after enrollment
Measured over 2 Weeks
+1 more outcome measured

Conditions

Endometrial Carcinoma
Obesity
EIN
Endometrial Intraepithelial Neoplasia
Endometrial Cancer Stage I

Explore related trials

Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial NeoplasiaEndometrial Carcinoma

Where it's being run

2 sites across 1 states
Massachusetts2

Study leadership

  • Colleen Feltmate, MD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital

Who to contact

Colleen Feltmate, MD
[email protected]
617-732-8840
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • proportion of patients who schedule an appointment and speak with a surgeon 1-2 weeks after enrollment2 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)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).