Ingestion of Simethicone After Capsule Ingestion and Its Impact on Quality of Video Capsule Endoscopy- a Pilot Study

Study Overview
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Brief Summary
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Wireless video capsule endoscopy (VCE) is a non-invasive technology that looks into small intestine and gives images of its lumen as the wireless capsule passes through it. It is used widely to access this anatomically difficult part of the body that cannot be seen via either colonoscopy or endoscopy. Currently various studies have been done that give multiple comparisons between various bowel preparation in terms of quality of the small bowel visualization. No studies have been done where simethicone (Gas-X) is ingested after capsule swallowing. We intend to give patients simethicone 1 hour after capsule ingestion for two consecutive hours and compare results of capsule endoscopy outcomes like small bowel transit time (SBTT), diagnostic yield (DY), small bowel visualization quality (SBVQ) and completion rate (CR).

Detailed Description
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Currently various studies have been done that give multiple comparisons between various bowel preparation in terms of small bowel transit time (SBTT), diagnostic yield (DY), small bowel visualization quality (SBVQ), completion rate (CR). Studies suggest that using Polyethylene glycol (PEG) prep is significantly better compared to clear liquid and overnight fast in terms if SBVQ and DY (Rokkas et al 2009). Other studies have shown using simethicone 30 minutes before capsule ingestion increases visibility compared to clear liquid and PEG preparation but no significant difference in gastrointestinal transit time or examination completion rate (Wei et al 2008). No studies have been done where simethicone is ingested after capsule swallowing. Simethicone helps absorb the air bubble in the lumen which can improve the image quality. It decreases the surface tension of gas bubbles thereby dissolving them and preventing gas pockets from forming in GI system. It's often used over the counter for gas relief. Gastric emptying time is usually less than 5 hours, small bowel transit time is usually less than 6 hours, and colonic transit time is usually less than 59 hours (Rao et al 2009). Giving simethicone till 2 hours after swallowing capsule can help clear gas bubble before the capsule migrates into the small bowel. Albert et al 2004 gave patients 80mg simethicone before swallowing the wireless capsule for their study. Wei et al 2008 gave 300mg of simethicone 20 minutes before swallowing the capsule. Chen et al 2011 gave 20ml (40mg/ml) simethicone 30 minutes before capsule ingestion which amounts to 800 mg total. Current FDA recommendation for adults is 500mg maximum daily dose. The liquid form comes in concentration of 20mg/0.3ml which constitutes to 7.5 ml for 500mg dose.

Official Title
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Ingestion of Simethicone After Capsule Ingestion and Its Impact on Quality of Video Capsule Endoscopy- a Pilot Study

Conditions
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Video Capsule Endoscopy

Intervention / Treatment
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* Drug: Simethicone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients aged 18 and older patients undergoing capsule endoscopy for standard of care patients able to give consent for themselves Exclusion Criteria: • prisoners

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Control, Sham , Experimental
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>First group: Control Follow the current standard protocol used at Albany Medical Center that includes: Do not drink anything for an additional 2 hours after swallowing pill cam. After which patient may drink clear liquids Do not eat solid food until 4 hours after swallowing. After which patient may eat light that includes soup, toast. Return to clinic (RTC) 8 hours after to remove equipment Avoid carbonated beverages and gas forming foods for the completion of the 8-hours study period | |
| Sham Comparator: Sham<br>Receive 3 ml simethicone 20 minutes prior to capsule swallowing Do not drink anything for an additional 2 hours after swallowing pill cam. After which patient may drink clear liquids Do not eat solid food until 4 hours after swallowing. After which patient may eat light that includes soup, toast. Return to clinic (RTC) 8 hours after to remove equipment Avoid carbonated beverages and gas forming foods for the completion of the 8-hours study period. | Drug: Simethicone<br>* Giving simethicone before and after capsule ingestion.<br>|
| Experimental: Experiment<br>Receive 3 ml simethicone 20 minutes prior to capsule swallowing. Receive 3 ml simethicone 1 hours after capsule swallowing Receive 1.5 ml simethicone 2 hours after capsule swallowing Do not drink anything for an additional 1 hour after taking last simethicone dose. After which patient may drink clear liquids Do not eat solid food until 4 hours after swallowing. After which patient may eat light that includes soup, toast. Return to clinic (RTC) 8 hours after to remove equipment Avoid carbonated beverages and gas forming foods for the completion of the 8-hours study period. | Drug: Simethicone<br>* Giving simethicone before and after capsule ingestion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Small bowel visualization quality (SBVQ) |  | 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Small bowel transit time (SBTT), |  | 8 hours | 
| Diagnostic yield (DY) |  | 8 hours | 
| completion rate (CR) |  | 8 hours |