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Идёт набор NCT07043062

Laparoscopic Versus Open Surgical Repair of Genitovesical Fistula in Females

Без фазы С лечением Genitovesical Fistula

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: Open surgical Interference.
Кому может быть актуально
Состояния в реестре: Genitovesical Fistula. Базовые параметры: 25 лет — 70 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
Египет
Следующий шаг
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Официальное название

Laparoscopic Versus Open Surgical Repair of Genitovesical Fistula in Females :ِ A Prospective Comparative Non Randomized Study

Обзор

Fistula is an abnormal passway that connects two organs or vessels that do not connect normally. Genitourinary fistula refers to a fistula that occurs between reproductive tract organs (vagina, cervix, and uterus), and lower urinary tract (bladder, urethra, and pelvic ureters). It is a serious condition which can significantly influence the biological and psychological condition of women, with a negative impact on the quality of life.

Подробное описание

Fistula is an abnormal passway that connects two organs or vessels that do not connect normally.

Genitourinary fistula refers to a fistula that occurs between reproductive tract organs (vagina, cervix, and uterus), and lower urinary tract (bladder, urethra, and pelvic ureters).

It is a serious condition which can significantly influence the biological and psychological condition of women, with a negative impact on the quality of life.

In developed countries, iatrogenic injury during hysterectomy or pelvic surgery is the primary cause of fistulae . However, the etiology differs in developing countries, being secondary to prolonged, obstructed, complicated labor.

Genitovesical fistulae are one of the most devastating complications in the urogynecology setting. The commonest type of these fistulae is the vesicovaginal fistula (VVF);the patients Suffering from continuous urinary leakage through the vagina and urinary smell, patients with VVF face hygienic, social, infectious, psychological, and sexual problems.

Vesicouterine fistulae (VUF) are not as common as VVF. In 1908, the first case was reported by Knipe , and later in 1957, Youssef reported on the classic symptoms of VUF. These symptoms included amenorrhea and cyclic hematuria, or menouria; known afterward as Youssef's syndrome. The prevalence of these fistulae is estimated to be 1-4% of all genitourinary fistulae.

Several options for the management of such fistulae have been discussed; these include conservative treatment with prolonged catheterization , open surgery, cysto-fulguration, endourology, and laparoscopy/robotic surgery. The decision-making is guided by the patient characteristics, etiology, and the experience of the treating surgeon.

Laparoscopy is of great advantage when compared to open surgery, including safe, effective, minimally invasive procedure, less postoperative pain, smaller incisions, lower blood loss, a shorter hospital stay, and faster recovery. It is associated with a lower incidence of postoperative complications, including infections and improper wound healing

Вмешательства

  • Процедура Open surgical Interference
    to compare the outcomes of Laparoscopic repair versus Open surgical repair of Genitovesical fistula in females.

Первичные конечные точки

  • Treatment of Genitourinary fistula [Срок оценки: From base line to 2 Months from the starting of the operation]

Критерии участия

Критерии включения

  • Females with Vesicovaginal fistula or Vesicouterine fistula.
  • Timing of repair after 2-6 months of beginning of symptoms and signs of fistula.

Критерии исключения

  • Malignant , Recurrant or Post Radiation Genitovesical fistula.
  • Females with congenital disease in Bladder ,Uterus or Vagina.
  • Females with Vaginal or Uterine prolapse.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • South Valley University Hospital — Qina

Идентификаторы

NCT: NCT07043062 · Female Genitovesical fistula

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗