Intrauterine Stent Placement Following Hysteroscopic Septum Resection
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: Intraoperative placement of an inflated intrauterine pediatric foley catheter, No Catheter placement, Hormonal Therapy Agent, Oral antibiotics.
- Кому может быть актуально
- Состояния в реестре: Intrauterine Adhesion. 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
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Randomized Controlled Trial of Intrauterine Stent Placement Following Hysteroscopic Septum Resection
Обзор
The study hopes to learn the best way to prevent internal scar tissue after septum removal. The use of an intrauterine foley catheter balloon may prevent the formation of adhesions following surgery.
Подробное описание
This is an open label randomized controlled clinical trial of post-operative interventions to prevent intrauterine adhesion formation following hysteroscopic septoplasty. Individuals undergoing planned hysteroscopic resection of a known uterine septum with a length of ≥50% of the uterine cavity, as measured from the lower uterine segment to the inter-cornual line on 3D ultrasound or MRI will be randomized to either placement of an intrauterine foley catheter balloon for 7-10 days with hormonal supplementation or hormonal supplementation only. Individuals unwilling or unable to consent, those with a history of prior transmural uterine surgery, those with a history of a prior septum resection, history of prior surgery for intrauterine adhesions, or individuals in whom complete septum resection is unable to be performed in a single procedure will be excluded.
Patients will be screened by study investigators for eligibility. Patients will be identified if they are found to have a uterine septum during their evaluation for infertility or recurrent pregnancy loss or if previously identified by a referring provider. Investigators will obtain written informed consent in the patient's preferred language by person-to-person contact. Patients choosing to enroll will be randomized in a 1:1 allocation to one of two interventions:
Surgical technique in the form of electrocautery versus sharp resection will be at the surgeon's discretion. All patients will undergo a post-operative in-clinic 3D saline sonogram to assess adhesion formation within the first two menstrual cycles following the intervention, to be performed no later than 12 weeks following surgery.
Вмешательства
- Процедура Intraoperative placement of an inflated intrauterine pediatric foley catheter
Intraoperative placement of an inflated intrauterine pediatric foley catheter balloon to remain in place for 7-10 days following surgery. - Процедура No Catheter placement
No Intraoperative placement of an inflated intrauterine pediatric foley catheter balloon - Препарат Hormonal Therapy Agent
2 weeks of oral estradiol (2 mg daily) or transdermal (two 0.1 mg patches changed twice weekly) estradiol supplementation followed by 1 week of oral or transdermal estradiol (same dosing as above) with oral medroxyprogesterone acetate (10 mg daily) - Препарат Oral antibiotics
100 mg of oral doxycycline twice daily or other appropriate antibiotic in allergic patients to be given while the intrauterine stent is in place
Первичные конечные точки
- The rate of intrauterine adhesion formation following hysteroscopic septoplasty [Срок оценки: 12 weeks]
Вторичные конечные точки (6)
- Number of participants with Intraoperative complications [Срок оценки: 12 weeks]
- Number of participants with postoperative complications [Срок оценки: 12 weeks]
- Number of subjects completing postop intervention-hormone use [Срок оценки: 12 weeks]
- Patient compliance - Post Operative - #subject with balloon remaining in place to post op visit [Срок оценки: 12 weeks]
- Long Term Reproductive Outcome [Срок оценки: 3 years]
- Surgeon assessment of intervention modality [Срок оценки: 12 weeks]
Критерии участия
Критерии включения
- Age 18 and above
- Patients electing to undergo hysteroscopic septoplasty following an informed consent and shared decision making process
- Uterine septum of at least 50% of the uterine cavity length as quantified on 3-dimensional saline infusion ultrasound
Критерии исключения
- Unwilling or unable to provide informed consent
- History of prior uterine septum resection
- History of prior transmural uterine surgery
- Preexisting intrauterine adhesions or prior treatment for intrauterine adhesions
- Individuals in whom complete septum resection is unable to be performed as a single procedure
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 3 центра
- Arkansas Fertility & Gynecology — Little Rock
- Weill Cornell Medicine — New York
- University Hospitals — Cleveland
Идентификаторы
NCT: NCT07032506 · 24-04027291