A Prospective Randomized Trial in Comparison of Zero Calorie Carbonated Drink or Water as a Solvent in Sodium Phosphate for Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Palatability of the solution including willingness to repeat the preparation
研究概览
简要总结
This prospective randomized trial will be conducted in all patients undergoing elective colonoscopies from February 2020 to August 2020 in Dowites Operation Theater Endoscopy suite by surgical unit III, Civil Hospital Karachi. Patient will be select randomly based on inclusion criteria. Patients will be advised to take 90ml of sodium phosphate in 800ml solvent ( zero calorie soft drink and water). Patients will be nil per oral from midnight aside from clear liquids. Serum electrolytes, urea, creatinine will be measured after and before bowel preparation. Bowel preparation will be assessed by consultant during endoscopy. Questionnaire will be filled by PI for palatability, tolerance of solution, adverse effects, and willingness to repeat the preparation.
详细描述
This prospective randomized trial will be conducted in all patients undergoing elective colonoscopies from February 2020 to August 2020 in Dowites Operation Theater Endoscopy suite by surgical unit III, Civil Hospital Karachi. Patient will be select randomly based on inclusion criteria. Patients will be advised to take 90ml of sodium phosphate in 800ml solvent ( zero calorie soft drink and water). Patients will be nil per oral from midnight aside from clear liquids. Serum electrolytes, urea, creatinine will be measured after and before bowel preparation. Bowel preparation will be assessed by consultant during endoscopy. Questionnaire will be filled by PI for palatability, tolerance of solution, adverse effects, and willingness to repeat the preparation.
90ml of sodium phosphate will be added to 800ml of solvent and taken in divided doses one day prior to procedure. Whole solution will be finished 3 -4 hours before colonoscopy. The instructions about how to take the solution will be clearly explained at the time of booking. Complete Blood Count and hepatitis B and C screening as routine shall be done. All procedure will be carried out under monitored sedation by trained colorectal surgeon from the faculty
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Age > 18 years
- •Non-emergency / non urgent colorectal diseases (IBD, suspected colonic polyps, colorectal cancer)
- •Screening Colonoscopy
排除标准
- •Age <18 years Pregnancy Intestinal obstruction Unfit patient Acute or serious illness Coagulopathy Unwilling patients
研究组 & 干预措施
Water
Water will be used as solvent for sodium phosphate
干预措施: Sodium phosphate (Drug)
Water
Water will be used as solvent for sodium phosphate
干预措施: Water (Dietary Supplement)
Zero calorie carbonated drink
Zero calorie carbonated drink will be used as solvent for sodium phosphate
干预措施: Sodium phosphate (Drug)
Zero calorie carbonated drink
Zero calorie carbonated drink will be used as solvent for sodium phosphate
干预措施: Zero calorie carbonated drink (Dietary Supplement)
结局指标
主要结局
Palatability of the solution including willingness to repeat the preparation
时间窗: This will be collected at the procedure appointment which is expected to be 2-3 hours in length. This time will be labelled as time 0 and will be noted once. T
This will be assessed by a questionnaire to be filled by the patient on check-in for the colonoscopy procedure. It will be scored on a scale of 1 to 4 as excellent, good, satisfactory or bad; score 1 being excellent result.
次要结局
- Degree of bowel cleanliness.(This will be collected at the procedure appointment which is expected to be 2-3 hours in length.)
- Incidence of adverse effects.(This will be collected at the procedure appointment which is expected to be 2-3 hours in length. It will be noted once.)
- Completion time of preparation.(This will be assessed only once on check-in for the colonoscopy procedure.This will be collected at the procedure appointment which is expected to be 2-3 hours in length.)
研究者
Hina Noman
Senior Registrar, Surgical Unit III, Civil Hospital
Dow University of Health Sciences