About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female adults at least 18 years of age
A BMI of 35-39.99 and 1 or more severe obesity-related co-morbidities
Tissue diagnosis (usually endometrial biopsy) of grade 1 endometrial carcinoma or EIN.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral
Other interventionSee arm description
Treatment groups
Trial outcomes
Primary outcomes
proportion of patients who schedule an appointment and speak with a surgeon 1-2 weeks after enrollment
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)
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
Safety of the concurrent surgeries
compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population
Postoperative complications
compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population
Time under anesthesia
compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population
Total time in operating room
compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population
Sponsors and contacts
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Dana-Farber Cancer Institute
Lead sponsor
Brigham and Women's Hospital
Sponsor institution