Usefulness Of Flospan As A Premedication For Colonoscopy

Study Overview
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Brief Summary
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Usefulness of Flospan as a premedication for colonoscopy: A randomized double-blind controlled trial

Detailed Description
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Cimetropium bromide is premedication of colonoscopy. However, it is contraindication for some diseases; benign prostatic hyperplasia(BPH) or other obstructive uropathy, intestinal obstruction, pyloric stenosis, glaucoma, myasthenia gravis, megacolon, paralytic ileus. In this cases, Flospan (phloroglucin) is effective alternative drug. So our research was to compare the effects of these two drugs.

Official Title
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Usefulness Of Flospan As A Premedication For Colonoscopy : A Randomized Double Blind Controlled Trial

Conditions
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Colonoscopy

Intervention / Treatment
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* Drug: Phloroglucin
* Drug: Cimetropium bromide
* Procedure: Colonoscopy
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recipient endoscopic diagnostic purposes. Exclusion Criteria: If you currently pregnant, or of childbearing potential Previous abdominal surgery or bowel resection. If under 18 years of age If the last two days, the administration of anticholinergic

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phloroglucin & Placebo<br>Phloroglucin 20ml before examination & Placebo 1ml before examination | Drug: Phloroglucin<br>* Premedication of colonoscopy<br>* Other names: Flospan;Procedure: Colonoscopy<br>* Diagnostic examination of colon<br>* Other names: Diagnostic examination of colon;Drug: Placebo<br>* Placebo for double-blind study These are harmless to the human body, and are composed of saline solution without drug efficacy.<br>|
| Experimental: Cimetropium bromide & Placebo<br>Cimetropium bromide 1ml before examination & Placebo 20ml before examination | Drug: Cimetropium bromide<br>* Premedication of colonoscopy<br>* Other names: Algiron;Procedure: Colonoscopy<br>* Diagnostic examination of colon<br>* Other names: Diagnostic examination of colon;Drug: Placebo<br>* Placebo for double-blind study These are harmless to the human body, and are composed of saline solution without drug efficacy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non inferiority of phloroglucin to cimetropium bromide | Comparing the two groups of time of examination, frequency of peristalsis, Scoring for the experimenter and the subject of the inspection feedback, double-blind setting. | Up to ten months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total diagnostic colonoscopy exam time |  | 1 year | 
| Evaluation of practitioners | Colonic motility and test difficulty | 1 year | 
| Evaluation of subjects | The degree of discomfort after test | 1 year | 
| Peristalsis time of transverse colon | Total peristalsis time of transverse colon for two minutes | 1 year | 
| Total dose and times of sedatives for pain control | Total dose and times of sedatives (midazolam, propofol) for pain control | 1 year | 
| Time of cecal intubation | Total time of colonoscope intubation from anus to cecum | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, Anticholinergics