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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04839614
• Other study ID #: 19-419
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: July 2023
• Source: Dana-Farber Cancer Institute
• Contact: Colleen Feltmate, MD
• Phone: 617-732-8840
• Email: cfeltmate[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

The most common risk factor for endometrial cancer is obesity. However, because early-stage endometrial cancer has a very high survival rate, patients more often suffer from long-term issues related to their weight, like heart disease, stroke, and diabetes. Weight loss surgery has been shown to help patients lose weight and also decrease their risk for obesity-related diseases. This research study is a Feasibility Study. This is the first-time investigators are studying both 1) the referral process of patients with endometrial cancer to the Center for Metabolic and Bariatric Surgery without delaying curative treatment of endometrial cancer 2) the combined surgery of both hysterectomy and weight loss surgery. The combined surgery of hysterectomy and weight loss surgery has been performed both at this institution and others without increased complications, but it has not been formally studied. Approximately 30 patients are expected to participate in this study at Brigham and Women's Hospital (BWH).

Other known NCT identifiers

• NCT04278183

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma in Situ
• EIN
• Endometrial Cancer Stage I
• Endometrial Carcinoma
• Endometrial Hyperplasia
• Endometrial Intraepithelial Neoplasia
• Endometrial Neoplasms
• Neoplasms
• Obesity
• Weight Loss

Intervention

Other:
• CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral
See arm description

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 Weeks
Primary	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).	up 12 weeks
Secondary	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	3 weeks
Secondary	Postoperative complications	compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population	3 weeks
Secondary	Time under anesthesia	compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population	1 Day
Secondary	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	1 Day
Secondary	Postoperative weight loss	Paired t-test or Wilcoxon rank sum test will be used to compare pre- and post-surgical outcomes and survey responses	6 months, 1 year
Secondary	Changes in lab values reflecting comorbid conditions	Paired t-test or Wilcoxon rank sum test will be used to compare pre- and post-surgical outcomes and survey responses	6 months, 1 year
Secondary	Post Operative 12-item Short Form Healthy Survey (SF-12) Survey	12-item Short Form Healthy Survey (SF-12) Survey	6 months