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Идёт набор NCT07434687

Comparison of Extended Totally Extra-peritoneal Repair (ETEP) and Subcutaneous On-lay Endoscopic Approach (SCOLA) for Para-umbilical Hernia (PUH).

Без фазы С лечением Paraumbilical Hernia

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: Extended Totally Extra Peritoneal Repair, Subcutaneous On-Lay Endoscopic Approach.
Кому может быть актуально
Состояния в реестре: Paraumbilical Hernia. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Пакистан
Следующий шаг
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Официальное название

Comparison of Extended Totally Extra Peritoneal Repair (ETEP) and Subcutaneous Onlay Endoscopic Approach (SCOLA) for the Treatment of Para Umbilical Hernias (PUH) in Terms of Intraoperative Factors(Operative Time, Hernial Contents, Divarication of Recti, Conversion to Any Other Technique) and Postoperative Complications( Surgical Site Infection, Seroma Formation, Postoperative Pain, Rescue Analgesia, Drain Output)

Обзор

The goal of this clinical trial is to learn if one of two surgical techniques works better for treating paraumbilical hernias in adult men and women between 18 and 65 years old. The main questions it aims to answer are: Does one technique lead to fewer complications after surgery, such as infection or fluid buildup (seroma)? Does one technique result in less pain or a shorter operating time? Researchers will compare the ETEP repair group to the SCOLA repair group to see if one method leads to better outcomes for patients. Participants will: Be randomly assigned to receive either the ETEP or SCOLA surgical repair. Have their surgery and recovery tracked by the research team. Attend follow-up visits for up to six months to check for any complications.

Вмешательства

  • Процедура Extended Totally Extra Peritoneal Repair
    The eTEP (Extended Totally Extra-Peritoneal) approach is a minimally invasive "keyhole" surgery for repairing hernias like paraumbilical hernias. Its core principle is to access the area behind the abdominal muscles without entering the main abdominal cavity. The surgeon creates a workspace between the muscle and its inner lining. A key step is crossing behind the midline to access both sides of the abdomen. The hernia is pushed back into place, and the inner lining is closed. A standard, low-c
  • Процедура Subcutaneous On-Lay Endoscopic Approach
    The Subcutaneous Onlay Endoscopic Approach (SCOLA) is a minimally invasive technique for repairing hernias near the belly button. In this approach, the surgeon works in the fatty layer between the skin and the abdominal muscles. After pushing the hernia back into place, the hole in the abdominal wall is stitched closed. A large mesh is then placed in this fatty layer, just in front of the muscles, to act as a strong reinforcement patch. The main benefit is that the mesh never touches the inter

Первичные конечные точки

  • Operative Time [Срок оценки: 4 hours]
  • Conversion to Any Other Procedure [Срок оценки: 4 hours]
  • Seroma Formation [Срок оценки: 6 months]
  • Surgical Site Infection [Срок оценки: 1 month]
  • Hernial contents [Срок оценки: 4 hours]
  • Divarication of recti [Срок оценки: 4 hours]
  • Postoperative pain [Срок оценки: 6 month]
  • Rescue analgesia [Срок оценки: 1 month]
  • Drain out put [Срок оценки: 1 month]

Критерии участия

Критерии включения

  • Adults of the age group from 18 to 65 years
  • Patients of both genders admittes with the diagnosis of para-umbilical Hernias through the outdoor department, documented on clinical examination by a consultant general surgeon.

Критерии исключения

  • Patients with a hernial defect more than 5cm, documented in the perioperative findings
  • Patients with complicated hernias, including irreducible and obstructed varieties, documented on clinical findings.
  • Patients who require abdominoplasty, opinion given by the operative surgeon.
  • Patients with intermediate to high risk of MACE during the surgery, documented on the fitness form filled by the cardiology team.
  • Patients with previous midline incision or laparotomy, documented on clinical examination.

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

Пакистан · 1 центр
  • King Edward Medical University/Mayo Hospital Lahore — Lahore

Идентификаторы

NCT: NCT07434687 · 340/RC/KEMU

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗