The Effectiveness of Simethicone In Improving Visibility During Colonoscopy
1 other identifier
interventional
194
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2006
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 1, 2008
CompletedFirst Posted
Study publicly available on registry
February 14, 2008
CompletedFebruary 22, 2013
February 1, 2013
1 year
February 1, 2008
February 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visibility: air bubble and haziness
During colonoscopy
Secondary Outcomes (1)
Total colonoscopic time, patient and doctor satisfaction and side effects
During colonscopy
Study Arms (2)
2
PLACEBO COMPARATOR1
ACTIVE COMPARATORInterventions
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
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
Eligibility Criteria
You may qualify if:
- \- Patients with age 18-70 yrs old who undergo colonoscopy at the endoscopic unit of the hospital
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ramathibodi hospital
Bangkok, Bangkok, 10400, Thailand
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Abhasnee Sobhonslidsuk, M.D.
Ramathibodi Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
February 1, 2008
First Posted
February 14, 2008
Study Start
December 1, 2006
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
February 22, 2013
Record last verified: 2013-02