Obesity > CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY

Hysterectomy and Weight Loss Surgery for Endometrial Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen By Colleen Feltmate, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Pregnancy, Active smoking, Substance abuse, others

No Placebo Group

Approved in 2 jurisdictions

Trial Summary

What is the purpose of 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).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY for endometrial cancer?

Research shows that bariatric surgery (weight loss surgery) is a safe and effective way to achieve rapid weight loss in extremely obese patients, which can make them eligible for further cancer treatment like hysterectomy (removal of the uterus). Additionally, laparoscopic surgery (a minimally invasive surgery using small incisions) for endometrial cancer in obese patients has been shown to reduce complications and improve recovery compared to open surgery.

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Is concurrent hysterectomy and weight loss surgery safe for humans?

Bariatric surgery (weight loss surgery) is considered safe and effective for rapid weight loss in extremely obese patients, which can help in managing endometrial cancer. However, specific safety data on performing hysterectomy and weight loss surgery at the same time is not well-documented in the available research.

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How is the treatment of concurrent laparoscopic hysterectomy and weight loss surgery unique for endometrial cancer?

This treatment is unique because it combines a hysterectomy (removal of the uterus) with bariatric surgery (weight loss surgery) in one procedure, which can be particularly beneficial for patients with endometrial cancer who are also morbidly obese. This approach not only addresses the cancer but also helps in significant weight reduction, potentially improving overall health and eligibility for cancer treatment.

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Eligibility Criteria

This trial is for adult women with a diagnosis of grade 1 endometrial cancer or EIN, who are obese (BMI of 35-40 with severe obesity-related conditions or BMI ≥ 40). They must be able to read English consent forms and agree to participate. Excluded are those under 18, pregnant, smokers, have had previous bariatric surgery, active substance abuse issues, certain psychiatric conditions, or higher-grade cancer.

Inclusion Criteria

My biopsy shows I have grade 1 endometrial cancer or EIN.

My BMI is over 35 with serious health issues or over 40.

I have a health condition like diabetes, high blood pressure, or severe obesity, or my BMI is 40 or more.

Exclusion Criteria

Pregnant participants

Inability to read an English informed consent form

Unwillingness to provide informed consent

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-surgery Preparation

Schedule a series of appointments with a bariatric surgeon, nutritionist, and psychologist as part of the approval process for weight loss surgery

2 weeks

Multiple visits (in-person)

Concurrent Surgery

Hysterectomy and weight loss surgery scheduled on the same day within 8 weeks from first visit with the gynecologic oncologist for endometrial cancer or 12 weeks for EIN patients

1 day

1 visit (in-person)

Post-operative Follow-up

Series of post-operative visits with the bariatric surgeon, gynecologic oncologic surgeon, nutritionist, and psychologist

3 weeks

Multiple visits (in-person)

Long-term Follow-up

Participants are monitored for changes in lab values reflecting comorbid conditions and postoperative weight loss

6 months to 1 year

Participant Groups

The study tests the feasibility of quickly referring patients diagnosed with obesity and early-stage endometrial cancer or EIN for concurrent weight loss surgery and hysterectomy within an eight-week period from their first oncology appointment.

Group I: CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY Experimental Treatment 1 Intervention

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.

CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Concurrent Laparoscopic Hysterectomy and Bariatric Surgery for:

• Obesity-related endometrial carcinoma
• Endometrial intraepithelial neoplasia (EIN)

🇪🇺 Approved in European Union as Concurrent Laparoscopic Hysterectomy and Bariatric Surgery for:

• Obesity-related endometrial carcinoma
• Endometrial intraepithelial neoplasia (EIN)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Dana-Farber Cancer Institute Boston, MA

Brigham and Women's Hospital Boston, MA

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute Lead Sponsor

References

1. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Laparoscopic radical hysterectomy with pelvic lymph node dissection for endometrial cancer in obese patients]. [2014] The results of treatment of 61 endometrial cancer patients with various forms of obesity are presented. Two groups of patients were compared: the first group comprised 26 patients who had undergone the laparoscopic surgery; the second group included 35 patients who had open surgery. Te laparoscopic approach improved the results of surgical treatment of endometrial cancer in patients with obesity. This technique allowed to reduce intraoperative blood loss, to diminish the duration of analgesics' administration, to shorten the period of bowel function recovery, 3 times to reduce the incidence of postoperative complications.

2. England pubmed.ncbi.nlm.nih.gov

Morbidly obese patient with endometrial cancer treated by bariatric surgery to enable cancer treatment. [2023] The case demonstrates the use of bariatric surgery to improve a patient's candidacy for surgical treatment for endometrial cancer (EC). A 50-year-old morbidly obese woman with early-stage EC was initially treated with levonorgestrel-releasing intrauterine system (52 mg) . She had to reduce her body mass index (BMI) to become eligible for definite EC treatment. Using conservative methods, she was unable to lose weight effectively. She then underwent bariatric surgery that reduced her BMI from 71.3 to 54.3 kg/m2 She maintained her weight and was eligible for total hysterectomy and bilateral salpingo-oopherectomy. Her procedure was successful and had no complications. She has 6-monthly follow-ups, and the most recent review showed no evidence of recurrence.

3. United States pubmed.ncbi.nlm.nih.gov

Endometrial cancer and bariatric surgery: A scoping review. [2020] Endometrial cancer is strongly associated with obesity, and weight reduction has been demonstrated to decrease risk and overall mortality. Bariatric surgery results in the most dramatic weight loss among morbidly obese individuals, and the impact of bariatric surgery on endometrial cancer requires further investigation.

4. Netherlands pubmed.ncbi.nlm.nih.gov

Bariatric surgery after failed conservative management in a morbidly obese patient with endometrial cancer. [2020] •Extreme obesity may preclude patients from primary surgical management of endometrial cancer.•Bariatric surgery is a safe and effective method of rapid weight loss in patients with extreme obesity.•Delayed hysterectomy, after weight loss from bariatric surgery, is an option in select patients with endometrial cancer.

5. United States pubmed.ncbi.nlm.nih.gov

Impact of Bariatric Surgery on Endometrial Cancer Tumor Pathology. [2021] Obesity is a well-established risk factor for endometrial cancer and is thought to adversely affect outcomes. The impact of significant and sustained weight loss as achieved by bariatric surgery for women with endometrial cancer is not well understood.

6. United States pubmed.ncbi.nlm.nih.gov

Bariatric surgery reduces odds of perioperative complications after inpatient hysterectomy: Analysis from a national database, 2016 to 2018. [2023] Increased body mass index is a known risk factor for increased adverse events post-hysterectomy. The effects of previous bariatric surgery on outcomes after inpatient hysterectomy are not well elucidated.

7. United States pubmed.ncbi.nlm.nih.gov

What's the impact of the obesity on the safety of laparoscopic hysterectomy techniques? [2012] To evaluate the impact of obesity in the safety of laparoscopic hysterectomy.

8. Greece pubmed.ncbi.nlm.nih.gov

Laparoscopic Versus Robotic Hysterectomy in Obese Patients With Early-stage Endometrial Cancer: A Single-centre Analysis. [2021] Label="BACKGROUND/AIM" NlmCategory="OBJECTIVE">To compare the surgical outcomes of robotic and laparoscopic hysterectomy with or without pelvic lymphadenectomy among obese patients [body mass index (BMI) >30 kg/m2] with early-stage endometrial cancer.