Recruiting

Laparoscopic Hysterectomy & Weight Loss Surgery

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT04839614

Conditions

Endometrial Carcinoma

Obesity

EIN

Endometrial Intraepithelial Neoplasia

Endometrial Cancer Stage I

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral

Study Details

Brief 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).

Conditions

Endometrial Carcinoma

Obesity

EIN

Endometrial Intraepithelial Neoplasia

Endometrial Cancer Stage I

Study ID

NCT04839614

Start date

Aug 1, 2021

Status verified date

Aug, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY

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.

Interventions

CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral

See arm description

Primary outcome measure

  • proportion of patients who schedule an appointment and speak with a surgeon 1-2 weeks after enrollment [ Time Frame: 2 Weeks ]
  • proportion of patients who undergo the concurrent surgeries within 8 weeks of diagnosis (12 weeks for EIN patients) [ Time Frame: up 12 weeks ]

Central Contacts and Locations

Central contacts

Colleen Feltmate, MD

617-732-8840cfeltmate@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Principal Investigator:

Colleen Feltmate, MD

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Principal Investigator:

Colleen Feltmate, MD

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Keywords

  • Endometrial Carcinoma
  • Obesity
  • EIN
  • Endometrial Intraepithelial Neoplasia
  • Endometrial Cancer Stage I
  • Weight Loss Surgery
  • Bariatric Surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-08-31.