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Trial NCT04839614

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

Phase
Not given
Sponsor
Dana-Farber Cancer Institute
Conditions
Endometrial Carcinoma; Obesity; EIN; Endometrial Intraepithelial Neoplasia; Endometrial Cancer Stage I
Ages
18+ years
View on ClinicalTrials.gov ↗

Eligibility criteria

Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).

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 < 35BMI * Without a tissue diagnosis, or with a grade 2 or greater endometrial cancer tissue diagnosis * Pregnant participants will be excluded from this study.Pregnancy * 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 illnessSmoking * include inability to read an English informed consent form, and unwillingness to provide informed consent.Language

Restrictions found (4)

Recruiting in Massachusetts

  • Brigham and Women's Hospital · Boston, Suffolk County
  • Dana-Farber Cancer Institute · Boston, Suffolk County