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临床试验/NCT04407793
NCT04407793Unknown不适用

Prospective and Multicentre Study on Clinical-biological Factors Predictive of Chronic Colon DIverticulitis

Sebastiano Biondo1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2020年5月25日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
试验地点
1
主要终点
Systemic inflammatory markers

研究概览

简要总结

MAIN OBJECTIVE: Description of predicted markers of acute diverticulitis crisis, using bivariate and multivariate analyses. Analysis of acute diverticulitis predictor swings.

SIDE OBJECTIVES: Descriptive analysis of HRQL in the different measurement periods to establish the evolution of the disease. Correlate HRQL values of systemic and local inflammatory markers in the diverticulitis group. Sub-analysis of patients with immunosuppression to evaluate disease virulence compared to a group of patients without immunosuppression.

STUDY TYPE: Clinical, observational, prospective and multicenter study (8 hospitals) with three study groups: patients diagnosed with acute diverticulitis attending emergencies, diverticulosis patients and patients without diverticulums. INCLUSION CRITERIA: Age > 18years and radiological diagnosis by abdominal CT acute diverticulitis. EXCLUSION CRITERIA: Rejection of the patient -severe diverticulitis requiring urgent surgery -an inability to understand HRQL questionnaire - IBD - pregnancy or breastfeeding - acute diverticulitis within the prior year of the study - Roma IV criteria fulfilment. VARIABLES: Main variables: local and systemic inflammatory markers- faecal calprotectin. Secondary variables: recurrence of acute diverticulitis -the persistence of symptoms - SF 12 and GIQLI questionnaires.

STATISTICS: Sample size: alpha error 0.05; beta error 0.20; bilateral; proportion 0.9 in the control group; 500 subjects group diverticulitis, 200 group diverticulosis and not diverticulums.

详细描述

GENERAL CHARACTERISTICS OF THE PROJECT:

Despite being a benign pathology, colon diverticulitis represents the fifth most important gastrointestinal pathology and has a great clinical impact on the quality of life of patients and on health expenditure. Understanding a disease involves being able to make the correct diagnosis of the patient and most importantly for the patient, an adequate treatment of his symptoms. It is required to give accurate information to the patient and answer his doubts, although the pathophysiology of the disease is unknown. As it is a benign disease with heterogeneous behaviours and manifestations, it is difficult to make the decision related to undergo surgery. This decision could be facilitated if it is based on extensive information from the doctor. It is also important to be able to select those patients who have a higher risk of relapse in order to prioritize them on the waiting list for surgery. As a benign disease with occupational active patient involvement, acute diverticulitis has a major economic impact by leading to repeat leaves in some patients, who are even on a waiting list to operate.

EXPECTED IMPACT:

We believe that this project can respond to the management of a group of patients, in which there is currently no consensus in the Scientific Community. Therefore, our results are transferable, as we intend to establish the pathophysiology of the entity known as chronic diverticulitis and detect the predictors of that entity. Currently, there is no consensus on the therapeutic management of patients with recurrent episodes of diverticulitis or persistent symptoms, so that they are treated differently at the discretion of the surgeon, without any scientific basis. It is also unclear whether it is a maintained inflammatory disorder or a functional disorder, which differentiation is basic in order to indicate a correct treatment of the patients. In addition, there is an information gap, unable to respond if a patient with acute diverticulitis will have a high or low probability of recurrence and at what time. There are still no studies answering these questions, key to choosing the best treatment and to give an answer to the huge population of diverticulitis patients.

HYPOTHESIS.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18years
  • Current episode of acute diverticulitis diagnosed with abdominal CT

排除标准

  • Rejection of the patient
  • Severe diverticulitis requiring urgent surgery
  • Inability to understand HRQL questionnaires
  • IBD background
  • Pregnancy or lactation
  • Acute diverticulitis episodes within the prior year to the start of the study
  • Patients who meet Roma IV criteria for IBS

结局指标

主要结局

Systemic inflammatory markers

时间窗: 2 years

To correlate systemic inflammatory markers with acute diverticulitis recurrence. \* Systemic inflammatory markers include: A blood test with leukocyte count and formula, C-reactive protein, albumin, Neutrophil-Lymphocyte ratio calculation, Platelet-lymphocyte ratio calculation, lymphocyte-monocyte ratio calculatio, Modified Glasgow Prognostic score calculation.

Faecal calprotectine

时间窗: 2 years

To correlate faecal calprotectine with acute diverticulitis recurrence

Recurrence of acute diverticulitis

时间窗: 2 years

To detect which patients with acute diverticulitis recur

Local inflammatory markers

时间窗: 2 years

To correlate local inflammatory markers with systemic inflammatory markers and recurrence. \*Local inflammatory markers come from colonic endoscopic samples taken in the colonoscopy at 2 months after the acute diverticulitis episode. 2 samples are taken: * Sample A: 1-5cm of diverticulum that has participated in diverticulitis episode (correlated with the CT) * Sample B: 30cm of the area that has suffered diverticulitis. Sampling for the study of local inflammatory markers includes IL-6, IL-10, tumour necrosis factor (TNF), macrophages, eosinophils and calculation of inflammation index of Ulcerative Colitis.

次要结局

  • HRQL (Health Related Quality of Life) QUESTIONNAIRES(2 years)

研究者

发起方
Sebastiano Biondo
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sebastiano Biondo

Sebastiano Biondo. Clinical Professor. Head of Surgery Department

Hospital Universitari de Bellvitge

研究点 (1)

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