Operative Versus Non-Operative Management for Appendicitis With Abscess or Phlegmon
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: Operative management, Drainage or antibiotics.
- Кому может быть актуально
- Состояния в реестре: Appendicitis. Базовые параметры: от 18 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
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The investigators aim to determine if early operative intervention is superior to non-operative management for adult patients with computerized tomography (CT)-proven complicated appendicitis with phlegmon or abscess.
Подробное описание
Complicated appendicitis with abscess or phlegmon represents a challenging problem to emergency general surgeons, and the preferred treatment remains controversial. A variety of therapies have been recommended including early operative intervention, delayed operative intervention, and non-operative management. Recently, a prospective randomized controlled trial from a single center was conducted in Finland comparing operative and non-operative management of appendiceal abscess. Patients managed in the operative arm were found to have a shorter length of stay, fewer re-admissions, and fewer additional interventions than those managed in the non-operative group, but there is no high-quality randomized control trial conducted in the United States to support this. The investigators, therefore plan to carry out a multi-center, patient choice study comparing operative and non-operative management of complicated appendicitis with abscess or phlegmon in the United States.
Вмешательства
- Процедура Operative management
Surgery for computer tomography (CT)-proven complicated appendicitis with phlegmon or abscess. - Другое Drainage or antibiotics
If an abscess is present and amenable to percutaneous drainage this will be performed. If there is no abscess or it is not amenable to drainage antibiotics alone will be provided.
Первичные конечные точки
- Number of hospital days [Срок оценки: Within 60 days of randomization.]
Вторичные конечные точки (12)
- Need for additional intervention for appendicitis [Срок оценки: Within one year of the index admission.]
- Intra-abdominal abscess [Срок оценки: More than 7 days after index admission but within 60 days of randomization.]
- Failed attempted procedure. [Срок оценки: Within 60 days of randomization.]
- Complications [Срок оценки: Within 60 days of randomization.]
- Number of interventions for abscess [Срок оценки: Within 60 days of randomization.]
- Need for bowel resection. [Срок оценки: Within 60 days of randomization.]
- Need for bowel resection [Срок оценки: Within 60 days of randomization.]
- Occurrence of delayed appendectomy [Срок оценки: Within one year of index admission.]
- Recurrence [Срок оценки: Within one year of index admission.]
- Presence of malignancy in any resected specimen [Срок оценки: Within one year of index admission.]
- Days of disability [Срок оценки: Within 60 days of randomization.]
- Gastrointestinal (GI) quality of life [Срок оценки: 30 days after randomization.]
Критерии участия
Критерии включения
1\. Complicated appendicitis with presumed perforation on (computer tomography) CT scan AND phlegmon or abscess greater than 2 centimeter (cm).
Критерии исключения
- Antibiotic therapy greater than 24 hours prior to considering for enrollment.
- Attempted drainage before randomization
- Pregnancy
- Antibiotic allergy requiring the use of something other than a beta-lactam or quinolone based therapy.
- Previous major intra-abdominal surgery by laparotomy
- Hospitalization within 2 weeks of randomization
- Presence of septic shock on admission.
- Mechanical ventilation
- Acute renal failure requiring dialysis
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 · 1 центр
- Yale New Haven Hospital — New Haven
Публикации
- Mentula P, Sammalkorpi H, Leppaniemi A. Laparoscopic Surgery or Conservative Treatment for Appendiceal Abscess in Adults? A Randomized Controlled Trial. Ann Surg. 2015 Aug;262(2):237-42. doi: 10.1097/SLA.0000000000001200. PMID 25775072
Идентификаторы
NCT: NCT04168866 · 2000026799 · No NIH funding