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Идёт набор NCT05393609

Quality of Life and Surgery in Diverticular Disease

— Наблюдательное Diverticulitis Colon Quality of Life Diverticular Disease of Left Side of Colon

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: Sigmoidectomy, Conservative.
Кому может быть актуально
Состояния в реестре: Diverticulitis Colon, Quality of Life, Diverticular Disease of Left Side of Colon. 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
Дания
Следующий шаг
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Обзор

Diverticular disease is one of the most common diseases of the gastrointestinal tract in industrial countries. Prevalence and admission rate due to diverticular disease increases. Symptomatic patients usually present with acute uncomplicated or complicated diverticulitis. Recurrence rates of complicated diverticulitis are estimated to 10-30%. Recurrences, chronic complications or persisting pain, here collectively referred to as chronic diverticular disease, may be treated by elective sigmoidectomy. Currently, there is no specific criteria for elective surgery, but only a recommendation of a tailored approach depending on the patient's symptoms. It is well established that diverticular disease has a negative impact on quality of life (QoL). Elective laparoscopic sigmoidectomy may increase QoL. In this prospective study, we will prospectively examine QoL, patient-related outcomes and peri- and postoperative outcome of elective sigmoidectomy for chronic diverticular disease, and compare it to conservatively treated patients.

Подробное описание

Design: Prospective, multicentre, observational

Locations: Hospitals in Central and Northern Denmark Region (6 hospitals).

Time: Recruitment starts in April 2022 and is planned to be completed in 2024.

Patients: All patients referred to a surgical clinic due to chronic diverticular disease.

Allocation for surgery or conservative treatment: Patients will be treated according to Danish National Guidelines for treatment of diverticular disease. The study will not influence the treatment of the patient, but only observe and evaluate current daily practice.

Intervention: Patients will be asked to answer questionnaires at inclusion and again after 1 year. Patients treated with sigmoidectomy will also be asked to answers questionnaires 3 weeks and 3 months after surgery.

Вмешательства

  • Процедура Sigmoidectomy
    Conventional laparoscopic resection of the sigmoid colon
  • Пищевая добавка Conservative
    According to current practice including advice on supplementary dietary fiber, analgetics, or laxatives when indicated.

Первичные конечные точки

  • Health related quality of life [Срок оценки: Change from baseline to 1 year follow-up.]
  • Disease-specific quality of life [Срок оценки: Baseline.]
Вторичные конечные точки (10)
  • Generic quality of life [Срок оценки: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.]
  • Bowel function [Срок оценки: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.]
  • Bowel function [Срок оценки: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.]
  • Pain related to diverticular disease [Срок оценки: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.]
  • Urinary dysfunction - females [Срок оценки: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.]
  • Urinary dysfunction - males [Срок оценки: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.]
  • Sexual dysfunction - females [Срок оценки: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.]
  • Sexual dysfunction - males [Срок оценки: Change from baseline to 3 weeks follow-up, 3 months follow-up and 1 year follow-up.]
  • Postoperative morbidity [Срок оценки: 30 days]
  • Postoperative mortality [Срок оценки: 30 days]

Критерии участия

Критерии включения

  • Referred to surgical clinic due to diverticular disease
  • Colonic diverticula verified by CT or endoscopy

Критерии исключения

  • Previous colonic resection other than appendectomy
  • Previous or current colorectal cancer
  • Previous or current disseminated cancer
  • Inflammatory bowel disease
  • Psychiatric disorder influencing the ability to answer questionnaires
  • Inadequate Danish

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Дания · 1 центр
  • Randers Regional Hospital — Randers

Идентификаторы

NCT: NCT05393609 · Life with diverticular disease

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗