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临床试验/NCT01783782
NCT01783782Unknown4 期

SMALL BOWEL CLEANSING FOR CAPSULE ENDOSCOPY IN PEDIATRIC PATIENTS: A PROSPECTIVE RANDOMIZED SINGLE-BLINDED STUDY

Azienda Policlinico Umberto I1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2005年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
200
试验地点
1
主要终点
Efficacy

研究概览

简要总结

The primary aim of this prospective, randomized and controlled study was to evaluate the effect of five bowel preparation regimens on small-bowel cleansing in a pediatric population. The secondary endpoints were to evaluate the safety and the effects of preparation on diagnostic yield of CE.

详细描述

Capsule endoscopy (CE) is a well-known, non-invasive, diagnostic tool to evaluate small bowel diseases in adults and children. Unfortunately, because CE does not have functions which allow suctioning of fluid or washing the small bowel mucosa during the examination, its diagnostic yield can be limited by presence of debris, biliary secretion, bubbles and blood in the gut lumen that may hide relevant findings especially in the distal small bowel. In addition, CE sometimes fails to reach the cecum within the battery life of the capsule, resulting in a failure to visualize the distal small intestine. However, in children this problem is less frequent for the increased intestinal motility, which reduces the transit time of the capsule.

It was believed that cleaning the small intestine prior to examination would improve mucosal visibility during the endoscopy and, as a result, the diagnostic yield of the technique. Therefore, proposals were put forward based on preparations for other types of explorations, such as colonoscopies (2).

Some authors have already studied in adults the effect of bowel preparation on small-bowel visualization using different agents; the results of the published series are contradictory. To date, while there is evidence for a benefit from bowel preparation for CE, there is so far no consensus on an optimal preparation regimen. In addition, in children there are not studies on this topic. Therefore, overnight fasting before the examination still remains the proposed preparation for capsule endoscopy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
盲法
Single (Investigator)

入排标准

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

入选标准

  • Patients undergoing elective Small Bowel capsule endoscopy in our Institution between 2 and 18 years of age were recruited for this study.

排除标准

  • intestinal obstruction,
  • suspicious impaired intestinal motility,
  • history of gastrointestinal surgery

研究组 & 干预措施

DIET

Experimental

Group A followed the standard regime consisting of a clear liquid diet for 12 hours on the day before CE, followed by an overnight fast.

干预措施: DIET (Behavioral)

HIGH PEG

Experimental

Group B received a high volume regime consisting of a 50 mL/Kg (up to 2 Lt/die) of polyethylene glycol 4000 solution with simethicon solution the evening before the examination, followed always by an overnight fast.

干预措施: polyethylene glycol 4000 solution with simethicon (Drug)

LOW PEG

Experimental

Group C, defined as a low volume regime, received 25 mL/Kg (up to 1Lt/die) of polyethylene glycol 4000 solution with simethicon solution the evening before the examination, followed by an overnight fast.

干预措施: polyethylene glycol 4000 solution with simethicon (Drug)

SIMETHICONE

Experimental

Group D received 20 mL oral simethicone (Panamir, DMG, Italy, containing 40 mg simethicone in 1mL emulsion) and 200mL water 30 minutes before capsule ingestion.

干预措施: simethicon (Drug)

SIMETH+PEG

Experimental

Group E received 25 mL/Kg (up to 1 Lt/die) of polyethylene glycol 4000 solution with simethicon solution followed by an overnight fast plus 20mL oral simethicone and 200mL water 30 minutes before capsule ingestion.

干预措施: polyethylene glycol 4000 solution with simethicon (Drug)

SIMETH+PEG

Experimental

Group E received 25 mL/Kg (up to 1 Lt/die) of polyethylene glycol 4000 solution with simethicon solution followed by an overnight fast plus 20mL oral simethicone and 200mL water 30 minutes before capsule ingestion.

干预措施: simethicon (Drug)

结局指标

主要结局

Efficacy

时间窗: During the performance of capsule endoscopy

Preparation efficacy was evaluated by the blinded endoscopist according to a visibility score. There is no standardized or validated scoring system for the quality of small-bowel cleanliness. The visibility of the mucosal surface was assessed as the percentage of visualized bowel surface area as follows: 1: \< 25%; 2: 25%-49%; 3: 50%-74%; 4: 75%-89%; 5: \> 90%.

次要结局

  • Safety(4 days)
  • Efficacy(during the reading capsule endoscopy)
  • clinical tolerabiity(On the morning of colonoscopy, immediately before the procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Giovanni Di Nardo

MD

Azienda Policlinico Umberto I

研究点 (1)

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