EFFICACY, TOLERABILITY, AND SAFETY OF DIFFERENT BOWEL PREPARATIONS FOR COLONOSCOPY IN CHILDREN
试验速览
- 阶段
- 4 期
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Efficacy
研究概览
简要总结
THE AIM OF THIS STUDY IS TO COMPARE THE EFFICACY, TOLERABILITY, AND SAFETY OF DIFFERENT BOWEL PREPARATIONS FOR COLONOSCOPY IN CHILDREN.
THE AIM OF THIS STUDY IS TO COMPARE THE OVERALL COLON CLEANSING
详细描述
COLONOSCOPY IS AN ESTABLISHED DIAGNOSTIC AND THERAPEUTIC TOOL IN A VARIETY OF GASTROINTESTINAL TRACT CONDITION AFFECTING CHILDREN AND ADOLESCENTs. FOR EXAMPLE: INFLAMMATORY BOWEL DISEASE, COLONIC POLYPS OR LOWER GASTROINTESTINAL TRACT BLEEDING.
THE IDEAL PREPARATION SHOULD BE OF LOW VOLUME, PALATABLE AND SUCCESSFUL IN COMPLETE COLON CLEANOUT.
PRIMARY AIMS OF THIS WERE TO COMPARE THE EFFICACY AND ACCEPTANCE OF FOUR METHODS OF BOWEL CLEANSING BEFORE COLONOSCOPY IN CHILDREN. SECONDARY AIMS WAS TO COMPARE THE SAFETY PROFILE OF THIS METHODS.
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
- 否
入选标准
- •Patients undergoing elective colonoscopy in our Institution between 2 and 18 years of age were recruited for this study.
排除标准
- •requirement for urgent colonoscopy,
- •bowel obstruction,
- •known or suspected hypersensitivity to the active or other ingredients,
- •clinically significant electrolyte imbalance,
- •prior intestinal resection,
- •known metabolic, renal and cardiac disease
结局指标
主要结局
Efficacy
时间窗: During the performance of colonoscopy
Preparation efficacy was evaluated by the blinded endoscopist according to the Boston Bowel Preparation scale (BBPS) consisting of four-point scoring system. The total score ranging from 0 to 9 was divided into four different classes: excellent cleansing (total score 8-9), good cleansing (total score 6-7), poor cleansing (total score 4-5) and inadequate cleansing (total score 0-3).
次要结局
- safety(4 days)
- clinical tolerabiity(On the morning of colonoscopy, immediately before the procedure)
- Compliance(On the morning of colonoscopy, immediately before the procedure)
- Acceptability(On the morning of colonoscopy, immediately before the procedure)
研究者
Giovanni Di Nardo
MD
Azienda Policlinico Umberto I