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Идёт набор NCT04839614

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

Без фазы С лечением Endometrial Carcinoma Obesity EIN Endometrial Intraepithelial Neoplasia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral.
Кому может быть актуально
Состояния в реестре: Endometrial Carcinoma, Obesity, EIN, Endometrial Intraepithelial Neoplasia. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Обзор

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).

Подробное описание

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.

This 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.

Approximately 30 patients are expected to participate in this study at Brigham and Women's Hospital (BWH).

Вмешательства

  • Другое CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral
    See arm description

Первичные конечные точки

  • proportion of patients who schedule an appointment and speak with a surgeon 1-2 weeks after enrollment [Срок оценки: 2 Weeks]
  • proportion of patients who undergo the concurrent surgeries within 8 weeks of diagnosis (12 weeks for EIN patients) [Срок оценки: up 12 weeks]
Вторичные конечные точки (7)
  • Safety of the concurrent surgeries [Срок оценки: 3 weeks]
  • Postoperative complications [Срок оценки: 3 weeks]
  • Time under anesthesia [Срок оценки: 1 Day]
  • Total time in operating room [Срок оценки: 1 Day]
  • Postoperative weight loss [Срок оценки: 6 months, 1 year]
  • Changes in lab values reflecting comorbid conditions [Срок оценки: 6 months, 1 year]
  • Post Operative 12-item Short Form Healthy Survey (SF-12) Survey [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

США · 2 центра
  • Brigham and Women's Hospital — Boston
  • Dana-Farber Cancer Institute — Boston

Идентификаторы

NCT: NCT04839614 · 19-419

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗