Меню
Набор скоро начнётся NCT07625852

Impact of Vertical vs. Transverse Closure on Outcomes of Laparoscopic Correction of Isthmocele

Без фазы С лечением Isthmocele

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: Vertical Closure, Transverse Closure.
Кому может быть актуально
Состояния в реестре: Isthmocele. Базовые параметры: 18 лет — 45 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

Laparoscopic repair of Isthmocele aims to restore the anatomical integrity and physiological function of the lower uterine segment. * Vertical Closure: This technique involves closing the defect along the longitudinal axis of the uterus. Proponents suggest it may be more anatomically aligned with the muscle fibers of the lower uterine segment, potentially leading to stronger scar formation and reduced tension. * Transverse Closure: This technique involves closing the defect perpendicular to the long axis of the uterus. This approach is more commonly used during primary cesarean sections. Arguments for transverse closure in isthmocele repair include familiarity for surgeons and potentially less shortening of the lower uterine segment. However, the actual impact of these different closure methods on long-term outcomes such as defect recurrence, scar integrity, and fertility, remains largely unexplored in a randomized controlled trial setting.

Подробное описание

Isthmocele, also known as a cesarean scar defect (CSD), is a common complication following cesarean section, characterized by a myometrial defect at the site of the hysterotomy scar. It can lead to various symptoms including abnormal uterine bleeding, dysmenorrhea, pelvic pain, and infertility.

Laparoscopic repair aims to restore the anatomical integrity and physiological function of the lower uterine segment.

* Vertical Closure: This technique involves closing the defect along the longitudinal axis of the uterus. Proponents suggest it may be more anatomically aligned with the muscle fibers of the lower uterine segment, potentially leading to stronger scar formation and reduced tension. * Transverse Closure: This technique involves closing the defect perpendicular to the long axis of the uterus. This approach is more commonly used during primary cesarean sections.

Arguments for transverse closure in isthmocele repair include familiarity for surgeons and potentially less shortening of the lower uterine segment.

However, the actual impact of these different closure methods on long-term outcomes such as defect recurrence, scar integrity, and fertility, remains largely unexplored in a randomized controlled trial setting.

Вмешательства

  • Процедура Vertical Closure
    The hysterotomy defect will be closed in two layers using interrupted or continuous sutures along the longitudinal axis of the uterus
  • Процедура Transverse Closure
    The hysterotomy defect will be closed in two layers using interrupted or continuous sutures perpendicular to the longitudinal axis of the uterus

Первичные конечные точки

  • Postoperative lower uterine segment scar thickness [Срок оценки: 6 and 12 months post-surgery using transvaginal ultrasound]

Критерии участия

Критерии включения

  • Women aged 18-45 years.
  • Diagnosis of symptomatic isthmocele confirmed by transvaginal ultrasound (myometrial thickness at the defect < 2.5 mm).
  • History of at least one prior cesarean section.
  • Symptoms attributable to isthmocele (e.g., abnormal uterine bleeding, pelvic pain, dysmenorrhea, secondary infertility).
  • Desire for surgical correction of isthmocele.
  • Ability to understand and provide informed consent

Критерии исключения

  • Asymptomatic isthmocele.
  • Active pelvic infection or malignancy.
  • Significant medical comorbidities contraindicating laparoscopic surgery.
  • Coagulopathy.
  • Known uterine anomalies (e.g., bicornuate uterus).
  • Pregnancy at the time of recruitment.
  • Inability to comply with follow-up protocol.

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
Простое слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07625852 · 1704-9-2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗