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CTRI Number  CTRI/2025/08/092832 [Registered on: 11/08/2025] Trial Registered Prospectively
Last Modified On: 08/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to find out if giving Simethicone (an anti-foaming medicine) to adults before colonoscopy helps get clearer views of the large intestine mucosa during procedure 
Scientific Title of Study   Visibility Improvement with Simethicone and Triple Sulfate Agent (OSS) for Colonoscopy: A Double-Blind, Placebo-Controlled Randomized Trial  
Trial Acronym  The VISTA trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Thirumoorthy 
Designation  Assistant Professor 
Affiliation  Cancer Institute (WIA), Adyar 
Address  Cancer Institute (WIA), 38 Sardar Patel Road, adjacent to I.I.T. Madras, Chennai

Chennai
TAMIL NADU
600036
India 
Phone  8056163348  
Fax    
Email  tmkarnikaa@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr L Sujatha 
Designation  Assistant Professor 
Affiliation  Cancer Institute (WIA), Adyar 
Address  Cancer Institute (WIA), 38 Sardar Patel Road, adjacent to I.I.T. Madras, Chennai

Chennai
TAMIL NADU
600036
India 
Phone  9500037675  
Fax    
Email  drsujatha@ymail.com  
 
Details of Contact Person
Public Query
 
Name  Dr L Sujatha 
Designation  Assistant Professor 
Affiliation  Cancer Institute (WIA), Adyar 
Address  Cancer Institute (WIA), 38 Sardar Patel Road, adjacent to I.I.T. Madras, Chennai


TAMIL NADU
600036
India 
Phone  9500037675  
Fax    
Email  drsujatha@ymail.com  
 
Source of Monetary or Material Support  
Delvin Formulations Pvt. Ltd. 
 
Primary Sponsor  
Name  Delvin Formulations Private Limited 
Address  5/A5, SIPCOT IT PARK, Third cross street, Siruseri 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sujatha  Cancer Institute (WIA)  38 Sardar Patel Road, adjacent to I.I.T. Madras, Chennai 600036
Chennai
TAMIL NADU 
9500037675

drsujatha@ymail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  15ml distilled water will be added to oral sulfate solution during colonoscopy preparation as placebo 
Intervention  Simethicone  Simethicone is an anti-foaming agent. 600mg (15ml) simethicone will be added to oral sulfate solution during colonoscopy preparation. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Adults between 18 to 70 years of age scheduled for colonoscopy at the gastroenterological unit
2. No clinical evidence of partial or complete colonic obstruction
3. Treatment naïve or follow up patients except patients who undergone right or left hemicolectomy
4. Written informed consent provided.
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Bowel Preparation Quality (BBPS Score)
2. Mucosal Visibility and Defoaming (CEBuS Score) 
During the procedure 
 
Secondary Outcome  
Outcome  TimePoints 
1. Colonoscopy Procedure Duration
2. Adverse events 
During the procedure 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/08/2025 
Date of Study Completion (India) 28/05/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Colonoscopy is one of the most common methods for the diagnosis and treatment of lower gastrointestinal tract diseases. Before colonoscopy it is required to prepare the colon. The patient will receive a bowel preparation solution containing magnesium sulfate, potassium sulfate and sodium sulfate. After this, only clear liquids will be permitted for four hours before the procedure. However, even with this preparation, the mucosal visualization, is impaired by the presence of stools, foam, or bubbles in most of the cases. Intraluminal foam and bubbles can hamper endoscopic visibility, potentially missing lesions and extending time of procedure.  To improve visualization of the colonic mucosa, it is possible to administer an oral solution of defoaming agent such as Simethicone prior to the procedure. Simethicone is a defoaming agent which decreases surface tension, leading to coalescing of foam and bubbles. Simethicone is not absorbed from the gastrointestinal tract and is not attached to other drugs, and rarely has adverse effects. It also helps reducing the time to flush with water to clear the mucous and also reduces the total time consumed to finish the endoscopy procedure.  Studies have demonstrated that simethicone enhances visualization during upper gastrointestinal endoscopy. Furthermore, several studies have reported that the addition of simethicone to bowel preparation prior to colonoscopy and small bowel capsule endoscopy can augment endoscopic mucosal visibility, improve diagnostic accuracy, and enhance endoscopist satisfactionDespite its potential benefits, the utilization of this solution for colonoscopy has not been evaluated in Indian populations. 

The Primary Objective of this study is to evaluate the impact of Simethicone on enhancing colonoscopy preparation quality, as determined by the Boston Bowel Preparation Scale (BBPS) and the Colon Endoscopic Bubble Scale (CEBuS). The Secondary Objective of this study is to assess and compare the procedure time between the two groups. This is a single-center, double-blind, placebo-controlled, prospective randomized controlled trial conducted at the Cancer Institute (WIA), Adyar, Chennai.

 


 
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