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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorDana-Farber Cancer Institute

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral

    Other intervention

    See arm description

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERYExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
2 Weeks
2

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).

Time frame
up 12 weeks

Secondary outcomes

1

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

Time frame
3 weeks
2

Postoperative complications

compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population

Time frame
3 weeks
3

Time under anesthesia

compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population

Time frame
1 Day
4

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

Time frame
1 Day

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dana-Farber Cancer Institute

Lead sponsor

Brigham and Women's Hospital

Sponsor institution