The Effectiveness of Simethicone In Improving Visibility During Colonoscopy

The Effectiveness of Simethicone In Improving Visibility During Colonoscopy: A Randomized, Placebo-controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Colonoscopy
• Intervention / Treatment: Drug: Placebo; Drug: Simethicone

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 Type: Interventional
• Enrollment (Actual): 194
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Ramathibodi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Visibility: air bubble and haziness	During colonoscopy

Secondary Outcome Measures

Outcome Measure	Time Frame
Total colonoscopic time, patient and doctor satisfaction and side effects	During colonscopy

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (ACTUAL): December 1, 2007
• Study Completion (ACTUAL): December 1, 2007

Study Registration Dates

• First Submitted: February 1, 2008
• First Submitted That Met QC Criteria: February 1, 2008
• First Posted (ESTIMATE): February 14, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): February 22, 2013
• Last Update Submitted That Met QC Criteria: February 21, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Bowel preparation, colonoscopy, simethicone, air bubble
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Antifoaming Agents; Emollients; Simethicone
• Other Study ID Numbers: ID12-49-23 (OTHER_GRANT: Gastroenterological Association of Thailand)