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| Sponsored by: |
Ramathibodi Hospital |
|---|---|
| Information provided by: | Ramathibodi Hospital |
| ClinicalTrials.gov Identifier: | NCT00615303 |
Purpose
Sodium phosphate is one of the bowel preparation regimens for colonoscopy. However, intraluminal gas can impair visibility during the examination. Simethicone is medication that works by reducing the surface tension of air bubbles. We aimed to evaluate the effect of simethicone in enhancing visibility and efficacy during colonoscopy.
| Condition | Intervention | Phase |
|---|---|---|
|
Colonoscopy |
Drug: Simethicone Drug: Placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | The Effectiveness of Simethicone In Improving Visibility During Colonoscopy: A Randomized, Placebo-Controlled Study |
| Enrollment: | 194 |
| Study Start Date: | December 2006 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 2: Placebo Comparator |
Drug: Placebo
2 dosages of either 45 ml of sodium phosphate plus 240 mg of simethicone tablets or 45 ml of sodium phosphate plus placebo in the evening before and in the morning of the procedure day
|
| 1: Active Comparator |
Drug: Simethicone
2 dosages of either 45 ml of sodium phosphate plus 240 mg of simethicone tablets or 45 ml of sodium phosphate plus placebo in the evening before and in the morning of the procedure day. The colonoscopic examination was recorded
|
A prospective, randomized, double-blinded, placebo-controlled study was conducted. One hundred and twenty-four patients were allocated to receive 2 dosages of either 45 ml of sodium phosphate plus 240 mg of simethicone tablets or 45 ml of sodium phosphate plus placebo in the evening before and in the morning of the procedure day. The colonoscopic examination was recorded. Visibility was blindly assessed for the amount of air bubbles and the degree of haziness by a single investigator. Five areas of the colon were graded for the amount of air bubbles, from 0 to 3; grade 0 and 1 were defined as the diminishing of air bubbles. The haziness was graded into 5 levels from excellent to unacceptable. Excellent, good and adequate were defined as the diminishing of haziness. The total duration of colonoscopy, the side effect of medication and the endoscopist and patient satisfaction were compared between 2 groups. Endoscopist satisfaction was evaluated by questionnaires. Visual analog scale (0-10) was used for rating patient satisfaction and the side effect of medication.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with age 18-70 yrs old who undergo colonoscopy at the endoscopic unit of the hospital
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Ramathibodi hospital ( Abhasnee Sobhonslidsuk, M.D. ) |
| Study ID Numbers: | ID12-49-23, ID12-49-23 |
| Study First Received: | February 1, 2008 |
| Last Updated: | February 1, 2008 |
| ClinicalTrials.gov Identifier: | NCT00615303 |
| Health Authority: | Thailand: Ethical Committee |
|
Bowel preparation, colonoscopy, simethicone, air bubble |
|
Simethicone Sodium phosphate |
|
Therapeutic Uses Gastrointestinal Agents Cathartics |
Dermatologic Agents Pharmacologic Actions Emollients |
