Actively Recruiting
Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia
Led by Dana-Farber Cancer Institute · Updated on 2025-08-07
30
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate a faster referral process for obese women diagnosed with early-stage endometrial cancer or endometrial intraepithelial neoplasia (EIN) to receive combined weight loss surgery and hysterectomy. The study focuses on how to safely schedule and perform these surgeries together without delaying cancer treatment, as obesity is a major risk factor for endometrial cancer and related health problems like heart disease and diabetes. This is a feasibility study conducted at Brigham and Women's Hospital involving about 30 participants. Participants will be referred from their gynecologic oncologist to the Center for Metabolic and Bariatric Surgery, where they will meet with a bariatric surgeon, nutritionist, and psychologist to complete the pre-surgery approval process. The combined laparoscopic hysterectomy and weight loss surgery will be scheduled on the same day within 8 weeks of the first gynecologic oncology visit for cancer patients, or within 12 weeks for those with EIN. After surgery, patients will have follow-up visits with the surgical team and support specialists. During the study, researchers will monitor the timing of appointments and surgeries, safety and complications from the combined procedures, time spent under anesthesia and in the operating room, and weight loss at 6 months and 1 year post-surgery. They will also assess changes in lab tests related to obesity-related conditions and quality of life using a health survey. Total participation includes the surgery and postoperative follow-up visits to track recovery and outcomes.
CONDITIONS
Brief Title
Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female adults at least 18 years of age
- Body mass index (BMI) of 35 to 39.99 with one or more severe obesity-related health conditions such as type 2 diabetes, hypertension, or sleep apnea, or a BMI of 40 or higher
- Tissue diagnosis of grade 1 endometrial carcinoma or endometrial intraepithelial neoplasia (EIN)
You will not qualify if you...
- Younger than 18 years old
- Body mass index (BMI) less than 35
- No tissue diagnosis or diagnosis of grade 2 or higher endometrial cancer
- Currently pregnant
- Contraindications to bariatric surgery including active smoking, previous bariatric surgery, active substance abuse, recent suicide attempt, bulimia nervosa, large abdominal hernias, or poorly controlled psychiatric illness
- Inability to read English informed consent form or unwillingness to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 weeks from first visit for endometrial cancer or up to 12 weeks for endometrial pre-cancer
Participants are referred to the Center for Metabolic and Bariatric Surgery and complete a series of appointments with a bariatric surgeon, nutritionist, and psychologist as part of the approval process for weight loss surgery.
Multiple visits with bariatric surgeon, nutritionist, and psychologist
Duration - 1 day
Participants undergo laparoscopic hysterectomy and weight loss surgery on the same day.
1 surgical procedure (in-person)
Duration - Up to 6 months to 1 year
Participants attend a series of post-operative visits with the bariatric surgeon, gynecologic oncologic surgeon, nutritionist, and psychologist to monitor recovery and health outcomes.
Multiple visits over several months
Trial Site Locations
Total: 2 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
C
Colleen Feltmate, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
1
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