[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04839614":3,"trial-entities:NCT04839614":120,"trial-summary:NCT04839614":124},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":23,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":39,"secondary_outcomes":48,"sex":70,"minimum_age":71,"maximum_age":72,"healthy_volunteers":14,"eligibility_criteria":73,"std_ages":88,"locations":91,"central_contacts":112,"overall_officials":116,"references":118,"see_also_links":119},"NCT04839614","19-419","Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia","RECRUITING","2028-06-30","2025-08","2025-08-07","2021-08-01","Dana-Farber Cancer Institute","OTHER",false,"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).","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.\n\nThis 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.\n\nApproximately 30 patients are expected to participate in this study at Brigham and Women's Hospital (BWH).",[18,19,20,21,22],"Endometrial Carcinoma","Obesity","EIN","Endometrial Intraepithelial Neoplasia","Endometrial Cancer Stage I",[18,19,20,21,22,24,25],"Weight Loss Surgery","Bariatric Surgery","INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[29],"NA",{"count":31,"type":32},30,"ESTIMATED",[34],{"type":13,"name":35,"description":36,"armGroupLabels":37},"CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral","See arm description",[38],"CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY",[40,44],{"measure":41,"description":42,"timeFrame":43},"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",{"measure":45,"description":46,"timeFrame":47},"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",[49,53,55,58,60,64,66],{"measure":50,"description":51,"timeFrame":52},"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",{"measure":54,"description":51,"timeFrame":52},"Postoperative complications",{"measure":56,"description":51,"timeFrame":57},"Time under anesthesia","1 Day",{"measure":59,"description":51,"timeFrame":57},"Total time in operating room",{"measure":61,"description":62,"timeFrame":63},"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",{"measure":65,"description":62,"timeFrame":63},"Changes in lab values reflecting comorbid conditions",{"measure":67,"description":68,"timeFrame":69},"Post Operative 12-item Short Form Healthy Survey (SF-12) Survey","12-item Short Form Healthy Survey (SF-12) Survey","6 months","FEMALE","18 Years",null,{"inclusion":74,"exclusion":79,"raw_text":87},[75,76,77,78],"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.",[80,81,82,83,84,85,86],"Younger than 18 years old","BMI \\\u003C 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.","Inclusion Criteria:\n\n* Female adults at least 18 years of age\n* A BMI of 35-39.99 and 1 or more severe obesity-related co-morbidities\n\n  --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\n* Tissue diagnosis (usually endometrial biopsy) of grade 1 endometrial carcinoma or EIN.\n\nExclusion Criteria:\n\n* Younger than 18 years old\n* BMI \\\u003C 35\n* Without a tissue diagnosis, or with a grade 2 or greater endometrial cancer tissue diagnosis\n* Pregnant participants will be excluded from this study.\n* Patients with contraindications to bariatric surgery will also be excluded.\n\n  --This includes active smokers, prior bariatric surgery, active substance abuse, recent suicide attempt, bulimia nervosa, large abdominal hernias, or poorly controlled psychiatric illness\n* include inability to read an English informed consent form, and unwillingness to provide informed consent.",[89,90],"ADULT","OLDER_ADULT",[92,107],{"facility":93,"status":7,"city":94,"state":95,"zip":96,"country":97,"contacts":98,"geoPoint":104},"Brigham and Women's Hospital","Boston","Massachusetts","02115","United States",[99,102],{"name":100,"role":101},"Colleen Feltmate, MD","CONTACT",{"name":100,"role":103},"PRINCIPAL_INVESTIGATOR",{"lat":105,"lon":106},42.35843,-71.05977,{"facility":12,"status":7,"city":94,"state":95,"zip":108,"country":97,"contacts":109,"geoPoint":111},"02215",[110],{"name":100,"role":103},{"lat":105,"lon":106},[113],{"name":100,"role":101,"phone":114,"email":115},"617-732-8840","cfeltmate@bwh.harvard.edu",[117],{"name":100,"affiliation":93,"role":103},[],[],{"nct_id":4,"conditions":121,"biomarkers":123},[122,18],"Endometrial Atypical Hyperplasia\u002FEndometrioid Intraepithelial Neoplasia",[],{"nct_id":4,"found":125,"summary":126,"prompt_version":136},true,{"design":127,"status":128,"heading":129,"summary":130,"follow_up":131,"word_count":132,"commitments":133,"compensation":134,"drugs_mentioned":135},"This is a feasibility study, meaning it's the first time these combined procedures and referral process are being formally studied. Approximately 30 patients are expected to participate.","completed","Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery for Endometrial Cancer","This study is looking at whether it's practical to quickly refer obese women with endometrial cancer or a pre-cancerous condition called endometrial intraepithelial neoplasia (EIN) for two surgeries at the same time: a laparoscopic hysterectomy (removal of the uterus using small cuts) and weight loss surgery. The goal is to see if these surgeries can be done together without delaying the cancer treatment. You might be able to join if you are an adult woman, at least 18 years old, with a BMI between 35 and 39.99, and have at least one obesity-related health problem like type 2 diabetes or high blood pressure. The study will consider it a success if a good number of patients schedule an appointment with a surgeon soon after joining, and if they have both surgeries within 8 weeks of diagnosis (or 12 weeks for EIN patients). The current status of this study is unclear.","The study measures outcomes up to 12 weeks after enrollment, focusing on the timing of appointments and surgeries.",150,"You would undergo concurrent laparoscopic hysterectomy and weight loss surgery. The study aims for these surgeries to occur within 8 weeks of diagnosis (or 12 weeks for EIN patients).","Not stated in the trial record.",[],"v2"]