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Идёт набор NCT03994978

Bowel Function/QoL After Elective Sigmoidectomy vs. Conservative Management for Recurrent Uncomplicated Diverticulitis

Наблюдательное Diverticulitis of Sigmoid

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: elective sigmoidectomy.
Кому может быть актуально
Состояния в реестре: Diverticulitis of Sigmoid. 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
Швейцария
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Preoperative vs. Postoperative Bowel Function and Quality of Life in Patients Undergoing Elective Sigmoidectomy vs. Conservative Management for Recurrent Uncomplicated Diverticulitis (FRESCO-Trial)

Обзор

The decision to perform a surgical intervention or not after recovery from repeated uncomplicated episodes of acute diverticulitis remains controversial and the literature shows different conflicting approaches based on low-quality evidence.The goal of this trial is to achieve a better understanding of the impact of surgery on bowel function and QoL in patients with recurrent uncomplicated sigmoid diverticulitis in order to develop treatment guidelines.

Подробное описание

The prevalence of diverticular disease of sigmoid in the Western has increased over the past century and our know-how of this disease and its management continues to evolve. International experts have tried to standardize the surgical approach to patients with recurrent episodes of sigmoid diverticulitis but, to date, no guidelines are universally recognized.The American Society of Colon and Rectal Surgeons (ASCRS) and the World Society of Emergency Surgery (WSES) recommend an individualized approach after recovery from uncomplicated acute diverticulitis to plan an elective sigmoid resection. The impact of ongoing disorders on quality of life (QoL) and not the number of previous episodes of diverticulitis should be the most determining factor. The German guideline by the Deutsche Gesellschaft für Allgemein- und Viszeralchirurgie (DGAV) recommend an elective sigmoid resection after a careful risk/benefit assessment depending on the clinical presentation in the disease-free interval in patients with chronic relapsing diverticulitis.The Danish Surgical Society (DSS) is more restrained and mentions the unnecessary risk in terms of morbidity and mortality to the individual as well as costs to society in prophylactic resection of the sigmoid. Therefore, they recommend that elective surgery should be probably limited to symptomatic cases not amenable to conservative measures. Moreover, recent studies have demonstrated that the number of attacks of diverticulitis is not necessarily a prevailing factor in defining the suitability of surgery and the operation itself carries significant morbidity and mortality. The German guidelines describe also a persistence of the symptoms in patients who underwent sigmoid resection in 22-25%. An uncomplicated diverticulitis is generally considered a mild and self-limiting disease, performing a potentially harmful procedure in these patients does not seem justified. However, elective resection may be an appropriate solution for a more selective group of patients who suffer greatly from their disease. Many studies have consistently shown that 40-80% remain symptomatic after conservative treatment, leading to impaired health-related Quality of life (HRQoL) and increased costs.

Вмешательства

  • Процедура elective sigmoidectomy
    elective sigmoidectomy

Первичные конечные точки

  • Change in grade of fecal incontinence incontinence score [Срок оценки: change from baseline to 12 months after intervention]
  • Change in grade of constipation [Срок оценки: change from baseline to 12 months after intervention]
Вторичные конечные точки (2)
  • Change in gastrointestinal quality of Life: gastrointestinal quality of life score" (GIQLI score) [Срок оценки: change from baseline to 12 months after intervention]
  • Change in erectile function [Срок оценки: change from baseline to 12 months after intervention]

Критерии участия

Критерии включения

  • Patients with recurrent uncomplicated diverticulitis and surgical indication for sigmoid resection
  • Patients with recurrent uncomplicated diverticulitis and non-surgical indication for conservative management
  • Confirmation of at least one episode of acute uncomplicated diverticulitis in computed tomography

Критерии исключения

  • Patients aged under 18.
  • Patients unable to understand an informed consent.
  • Patients with chronic pain disorder.
  • Patients with sigmoid fistulas
  • Emergency operations.
  • Pregnant women or lactation.
  • Patients with other severe gastrointestinal diseases, such as inflammatory bowel diseases (IBD), carcinoma or immunologic disorders.
  • Patients unable to perform surgery or high-risk patients according to the American Society of Anesthesiology (ASA 4 grade or higher)

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Швейцария · 1 центр
  • St. Claraspital Basel — Basel

Идентификаторы

NCT: NCT03994978 · FRESCO Trial

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗