Clincosm LogoSign in Get a demo

The Effectiveness of Simethicone In Improving Visibility During Colonoscopy

Sponsor
Ramathibodi Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00615303
Collaborator
(none)
194
Enrollment
1
Location
2
Arms
12
Duration (Months)
16.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
194 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effectiveness of Simethicone In Improving Visibility During Colonoscopy: A Randomized, Placebo-controlled Study
Study Start Date :
Dec 1, 2006
Actual Primary Completion Date :
Dec 1, 2007
Actual Study Completion Date :
Dec 1, 2007

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • sodium phosphate

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Visibility: air bubble and haziness [During colonoscopy]

    Secondary Outcome Measures

    1. Total colonoscopic time, patient and doctor satisfaction and side effects [During colonscopy]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    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:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ramathibodi hospital Bangkok Thailand 10400

    Sponsors and Collaborators

    • Ramathibodi Hospital

    Investigators

    • Study Director: Abhasnee Sobhonslidsuk, M.D., Ramathibodi Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abhasnee Sobhonslidsuk, Associate professor, Ramathibodi Hospital
    ClinicalTrials.gov Identifier:
    NCT00615303
    Other Study ID Numbers:
    • ID12-49-23
    • ID12-49-23
    First Posted:
    Feb 14, 2008
    Last Update Posted:
    Feb 22, 2013
    Last Verified:
    Feb 1, 2013
    Keywords provided by Abhasnee Sobhonslidsuk, Associate professor, Ramathibodi Hospital
    Bowel preparation, colonoscopy, simethicone, air bubble
    Additional relevant MeSH terms:
    Simethicone

    Study Results

    No Results Posted as of Feb 22, 2013