Combined Hysterectomy and Weight Loss Surgery for Obese Patients With Endometrial Cancer
Tests a combined hysterectomy and weight loss surgery in adults with obesity and endometrial cancer.
Key facts
- Who runs it
- Dana-Farber Cancer Institute
- Where
- Boston, United StatesSee the 2 sites
- Trial code
- Registry title
- Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia
- Status
- Recruiting
- People taking part
- 30 people, planned
- Started
- 1 Aug 2021
- Expected to end
- 30 Jun 2028
- Type of study
- Interventional
- Treatments tested
- CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral
- Record updated
- 31 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women with obesity and early-stage (grade 1) endometrial cancer or endometrial intraepithelial neoplasia (EIN). They would have womb removal and weight loss surgery at the same time.
- Age
- 18 years or older
- Sex
- Women only
- Disease stage
- Grade 1 endometrial carcinoma or EIN, confirmed by a tissue sample (usually an endometrial biopsy).
- Earlier treatment
- No prior weight loss (bariatric) surgery.
Main reasons for not taking part
- Grade 2 or higher endometrial cancer, or no tissue diagnosis
- BMI under 35
- Pregnancy
- Reasons weight loss surgery is unsafe, such as active smoking, active substance abuse, bulimia nervosa or poorly controlled psychiatric illness
- Cannot read an English consent form or is unwilling to give consent
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Without a tissue diagnosis, or with a grade 2 or greater endometrial cancer tissue diagnosis
- Younger than 18 years old
- BMI < 35
- Pregnant participants will be excluded from this study
- include inability to read an English informed consent form, and unwillingness to provide informed consent
Where in United States
- Brigham and Women's HospitalBoston, United StatesContact: Colleen Feltmate, MDTaking people
- Dana-Farber Cancer InstituteBoston, United StatesContact: Colleen Feltmate, MD (principal investigator)Taking people
About the trial
What the trial wants to find out
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).
The group in the trial
- CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERYTreatment being tested
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.
Treatment: CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia
- Plain-language title
- Combined Hysterectomy and Weight Loss Surgery for Obese Patients With Endometrial CancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 31 August 2026