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The Effectiveness of Simethicone In Improving Visibility During Colonoscopy

This study has been completed.
Sponsor:
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
History of Changes
  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:

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Dermatologic Agents
Emollients
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015