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临床试验/NCT01415687
NCT01415687已完成3 期

A Randomized Prospective Trial Comparing Pico-Salax (Magnesium Citrate) Plus Bisacodyl Versus Split Dose Polyethylene Glycol-Based Lavage In Preparation Of Patients For Colonoscopy

University of Calgary2 个研究点 分布在 1 个国家目标入组 171 人开始时间: 2011年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
171
试验地点
2
主要终点
Quality of Bowel Cleanliness

研究概览

简要总结

The objective of this study is to compare the efficacy, safety and tolerability of two bowel preparations for colonoscopy - split dose Polyethylene Glycol-Based Lavage and Pico-Salax plus Bisacodyl - with a specific emphasis on the right colon cleanliness.

The primary outcomes will be 1) quality of preparation in cleansing the colon, 2) quality of preparation in cleansing the right colon, 3) patient satisfaction. The secondary outcomes will be 1) duration of bowel preparation, 2) patient discomfort during bowel preparation.

详细描述

All patients referred to the Forzani MacPhail Colon Cancer Screening Centre (CCSC) in Calgary, Alberta, Canada for colonoscopy will be considered for inclusion. During pre-assessments at the clinic, patients are asked to consider a general research consent. If they agree to that, then they will be approached for consideration of participating in this study and presented with an "Invitation to Participate in a Research Study" form (appendix); the study assistant will obtain final consent if they agree. Those not interested in participating will simply receive their physician's standard bowel preparation protocol. There will be no coercion of any sort. Enrollment of participants will be performed with block randomizations of 8 by using a computer-generated table, with allocation concealment maintained through the use of consecutively numbered sealed envelopes. Colonoscopists and investigators will be blinded to allocation groups. Patients will be allocated to one of two groups: (1) oral Pico-Salax (two sachets, with 1.5-2L of water following each sachet) with Dulcolax (Bisacodyl, 4 tablets); (2) split dose Polyethylene Glycol-Based Lavage (2L + 2L).

A study assistant will assign patients to their group and instruct them on the proper use of their assigned bowel preparation method. Patients will be given a tolerability questionnaire, which has been modified from a previously used questionnaire, to be completed once their bowel preparation is finished and before coming to the CCSC for the colonoscopy (included in the appendix). Patient concerns or questions regarding the preparation will be directed toward the study assistant or clinic nurses as opposed to their endoscopist, so as to avoid un-blinding the Colonoscopist. The physician performing the procedure will then complete an Ottawa Bowel Preparation Scale and a validated Simplified Bowel Preparation scale to assess colon cleanliness.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 to 74 years referred to the in Calgary, Alberta, Canada for colonoscopy will be considered for inclusion

排除标准

  • Any history of kidney problems

研究组 & 干预措施

PEG Arm

Active Comparator

Patients randomized to this arm of the trial will be following preparation instructions using Polyethylene Glycol-Based Lavage in a split dose format

干预措施: Polyethylene Glycol-Based Lavage (Drug)

Pico-Salax + Bisacodyl Arm

Active Comparator

Patients randomized to this arm will follow preparation instructions using Pico-Salax preparation plus Biscacodyl in a split dose format

干预措施: Pico-Salax (Magnesium Citrate) plus Bisacodyl (Drug)

结局指标

主要结局

Quality of Bowel Cleanliness

时间窗: Scales provided to physician at time of colonoscopy, and filled out and collected after procedure is completed (1 hour time). Questionnaires are manually entered by an assistant into the study database on the same day as collection.

Ottawa bowel Prep scale will be done by the Dr. to assess the quality of bowel cleanliness. The right, mid and rectosigmoid colon are each rated on a 5-point scale (0-4). Also, a complete 3-point rating for overall colonic fluid is assessed giving an overall score range of 0-14. An excellent preparation would score 0-1; a good preparation, 2-4; while scores \>4 would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11-14, depending on the amount of fluid. A simplified overall cleanliness score will be completed and compared to the Ottawa scale.

次要结局

  • Patient Satisfaction with preparation(Questionnaire given on day of pre-screen and collected on day of colonoscopy, approximately 3 weeks.Patients are not followed or contacted past the day of colonoscopy.)

研究者

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

Alaa Rostom

MD MSc FRCPC

University of Calgary

研究点 (2)

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