| 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
|
|
|
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
|
|
|
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 |
|
|
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 satisfaction. Despite 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. |