The Effectiveness of Simethicone In Improving Visibility During Colonoscopy
This study has been completed.
Sponsor:
Ramathibodi Hospital
Information provided by (Responsible Party):
Abhasnee Sobhonslidsuk, Ramathibodi Hospital
ClinicalTrials.gov Identifier:
NCT00615303
First received: February 1, 2008
Last updated: February 21, 2013
Last verified: February 2013
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Effectiveness of Simethicone In Improving Visibility During Colonoscopy: A Randomized, Placebo-controlled Study |
Resource links provided by NLM:
Further study details as provided by Ramathibodi Hospital:
Primary Outcome Measures:
- Visibility: air bubble and haziness [ Time Frame: During colonoscopy ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Total colonoscopic time, patient and doctor satisfaction and side effects [ Time Frame: During colonscopy ] [ Designated as safety issue: Yes ]
| 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 |
|---|---|
| Placebo Comparator: 2 |
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
Other Name: Sodium phosphate
|
| Active Comparator: 1 |
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
Other Name: sodium phosphate
|
Detailed Description:
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 (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with age 18-70 yrs old who undergo colonoscopy at the endoscopic unit of the hospital
Exclusion Criteria:
- Renal insufficiency (Cr >2.3 mg/dl)
- Congestive heart failure
- Massive ascites
- Acute myocardial infarction within 6 months
- Coagulopathy
- Previous colonic surgery
- Suspected of colonic obstruction Pregnancy Refuse to give inform consent
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00615303
Please refer to this study by its ClinicalTrials.gov identifier: NCT00615303
Locations
| Thailand | |
| Ramathibodi hospital | |
| Bangkok, Thailand, 10400 | |
Sponsors and Collaborators
Ramathibodi Hospital
Investigators
| Study Director: | Abhasnee Sobhonslidsuk, M.D. | Ramathibodi Hospital |
More Information
| Responsible Party: | Abhasnee Sobhonslidsuk, Associate professor, Ramathibodi Hospital |
| ClinicalTrials.gov Identifier: | NCT00615303 History of Changes |
| Other Study ID Numbers: | ID12-49-23 ID12-49-23 |
| Study First Received: | February 1, 2008 |
| Last Updated: | February 21, 2013 |
| Health Authority: | Thailand: Ethical Committee |
Keywords provided by Ramathibodi Hospital:
|
Bowel preparation, colonoscopy, simethicone, air bubble |
Additional relevant MeSH terms:
|
Simethicone Antifoaming Agents Molecular Mechanisms of Pharmacological Action Emollients Dermatologic Agents |
ClinicalTrials.gov processed this record on September 29, 2016