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临床试验/NCT03753425
NCT03753425已完成不适用

Colonoscopy With Low Volume bowEl prepAration in iNflammatory Bowel Diseases

Centre Hospitalier Universitaire de Besancon1 个研究点 分布在 1 个国家目标入组 278 人开始时间: 2017年3月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
278
试验地点
1
主要终点
Boston Score

研究概览

简要总结

National multicentric observatory of low bowel preparations in patients with IBD

详细描述

Prospective french multicentre observational study, during one month: from March 6th to April 6th 2017, under the auspice of the IBD group of the Société Française d'Endoscopie Digestive- SFED. All French gastroenterologists in charge of IBD patients in public or private endoscopy centers were reached out through various professional and scientific associations to participate in the study via e-mail, web sites, and national congresses. Investigators were asked to prescribe the bowel preparation independently from the study, as per their usual habits. The achievement of low residue diet, the split and the timing of the preparation were left free to the investigator according to local protocols.

Data recording The physicians participating in the study completed data on an online questionnaire via an internet-based tool (CleanWeb software, hosted by Besançon university hospital research center) or through a questionnaire sheet. The questionnaire included a medical record and a self-reported patient questionnaire. The medical record included physicians and centers characteristics, patient's demographics, disease characteristics, modality of bowel preparation (diet, split dose, type of bowel preparation, delay before colonoscopy), and colonoscopy findings and outcomes. Patients self-administered questionnaires assessed preparation tolerability by symptoms and satisfaction recording.

Clinical endpoints The efficacy of the preparation was evaluated by the Boston's score (efficacy was defined as a Boston's score was ≥ 7 without any segment <2)23, the rate of caecal or anastomosis intubation and the necessity or not to repeat the colonoscopy.

The tolerance was evaluated by the quantity of preparation actually absorbed by the patient, (quantity of active preparation and quantity of clear liquid), patients and investigators visual analogue scale evaluation of tolerance (VAS), a self-administered validated bowel-preparation tolerability questionnaire 24 and by the patients' wish to take the same preparation for the next colonoscopy.

Safety data: adverse events were collected per preparation and per endoscopic procedure, at 24 hours and 30 days later. A special focus was made on aphtoid lesions as they were previously reported as adverse preparation-induced mucosal lesions possibly associated with some solutions.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient aged 18-75 years,
  • symptoms of IBD for at least 3 month,
  • inidcation of colonoscopy independent from the study.

排除标准

  • Congestive heart failure,
  • severe renal failure,
  • gastro intestinal symptomatic obstruction or occlusive bowel stenosis (a non-occlusive stenosis was not an exclusion criterion),
  • severe acute colitis,
  • severe dehydration or electrolyte disturbances,
  • patient's refusal to participate in the study.

结局指标

主要结局

Boston Score

时间窗: 30 days

According to the rate of complete colonoscopy (caecal intubation); and according to the need to reschedule the examination

次要结局

  • tolerance: visual analogue scale(30 days)
  • adverse events per procedure(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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