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
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)
- BMIOutrightexclusion
BMI < 35
Show in the text - LanguageOutrightexclusionShow in the text
- PregnancyOutrightexclusionShow in the text
- SmokingConditionalexclusionShow in the text
Recruiting in Massachusetts
- Brigham and Women's Hospital · Boston, Suffolk County
- Dana-Farber Cancer Institute · Boston, Suffolk County