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

Launched by DANA-FARBER CANCER INSTITUTE · Apr 7, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at the possibility of helping women with obesity who have early-stage endometrial cancer or a precancerous condition called endometrial intraepithelial neoplasia (EIN). The goal is to see if these patients can be quickly referred from their cancer doctor to a weight loss surgery team so they can have both weight loss surgery and a hysterectomy (removal of the uterus) done together within 8 to 12 weeks after their first appointment. This could help improve their health and treat their cancer more effectively.

To participate in this trial, women must be at least 18 years old, have a body mass index (BMI) between 35 and 40 with serious weight-related health issues, or a BMI of 40 or higher. They should also have a confirmed diagnosis of early-stage endometrial cancer or EIN. Participants can expect to receive coordinated care from both the cancer and weight loss teams, which could lead to better outcomes for their health. It’s important to note that certain individuals, such as those with more advanced cancer or specific health issues that make surgery risky, won’t be eligible to join this trial.

Gender

FEMALE

Eligibility criteria

• 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.