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CTRI Number  CTRI/2024/06/068842 [Registered on: 13/06/2024] Trial Registered Prospectively
Last Modified On: 12/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Efficacy of addition of oral simethicone on the quality of bowel preparation for colonoscopy 
Scientific Title of Study   Efficacy of addition of oral simethicone on the quality of bowel preparation for colonoscopy– a Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sukrati Maheshwari 
Designation  Senior Resident 
Affiliation  Kalinga Institute of Medical Sciences, Bhubaneswar 
Address  Department of Gastroenterology, Kalinga Institute of Medical Sciences, Bhubaneswar - Odisha

Khordha
ORISSA
751024
India 
Phone  8889994697  
Fax    
Email  sukarati@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Preetam Nath 
Designation  Professor 
Affiliation  Kalinga Institute of Medical Sciences, Bhubaneswar 
Address  Department of Gastroenterology, Kalinga Institute of Medical Sciences, Bhubaneswar

Khordha
ORISSA
751024
India 
Phone  9438870743  
Fax    
Email  preetam.nath@kims.ac.in  
 
Details of Contact Person
Public Query
 
Name  Sukrati Maheshwari 
Designation  Senior Resident 
Affiliation  Kalinga Institute of Medical Sciences, Bhubaneswar 
Address  Department of Gastroenterology, Kalinga Institute of Medical Sciences, Bhubaneswar

Khordha
ORISSA
751024
India 
Phone  8889994697  
Fax    
Email  sukarati@gmail.com  
 
Source of Monetary or Material Support  
Kalinga Institute of Medical Sciences, Bhubaneswar  
 
Primary Sponsor  
Name  Sukrati Maheshwari 
Address  Department of Gastroenterology, Kalinga Institute of Medical Sciences, Bhubaneswar - Odisha (751024) 
Type of Sponsor  Other [Self] 
 
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 
Sukrati Maheshwari  Kalinga Institute of Medical Sciences, Bhubaneswar  Department of Gastroenterology, Kalinga Institute of Medical Sciences, Bhubaneswar- Odisha (751024)
Khordha
ORISSA 
8889994697

sukarati@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE KALINGA INSTITUTE OF MEDICAL SCIENCE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K00-K95||Diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Polyethylene glycol electrolyte solution  The preparation will be given in split dose. 1 Litre of PEG-electrolyte solution will be given between 6pm to 7pm on the previous day of planned colonoscopy. This will be followed by liquid diet in evening. The next 1 Litre of PEG-Electrolyte solution will be given on the same day of colonoscopy between 6 to 7 a.m. 
Intervention  Simethicone with Polyethylene Glycol electrolyte solution  The preparation will be given in split dose. 300 mg of simethicone and 1 litre of PEG-electrolyte solution will be given between 6pm to 7pm on the previous day of planned colonoscopy. Followed by liquid diet in evening. The next dose of 300mg of oral simethicone and 1L of PEG-electrolyte solution will be given on the same day of colonoscopy between 6 to 7 a.m. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  74.00 Year(s)
Gender  Both 
Details  Consecutive adult patients aged between 18 and 74 years who were scheduled for diagnostic colonoscopy 
 
ExclusionCriteria 
Details  Previous history of abdominal surgery
Chronic kidney disease with eGFR less than 60ml per min per 1.73m2
Congestive heart failure with New York Heart Association class II to IV
Pregnancy or lactation
Inflammatory bowel disease
Psychiatric illness including diagnosed case of psychosis or schizophrenia or dementia
Any patient with suspected lower gastrointestinal bleed
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Boston Bowel Preparation Scale  Baseline, during colonoscopy 
 
Secondary Outcome  
Outcome  TimePoints 
Bubble score
Caecal intubation time
Withdrawal time
Adverse events
Adenoma detection rate
 
Baseline, during colonoscopy
 
 
Target Sample Size   Total Sample Size="224"
Sample Size from India="224" 
Final Enrollment numbers achieved (Total)= "224"
Final Enrollment numbers achieved (India)="224" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   30/07/2024 
Date of Study Completion (India) 31/10/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
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 considered to be the gold standard investigation for assessing colonic lesions; but many factors, such as the quality of bowel preparation, endoscopist, and patient factors, may affect the diagnostic accuracy and therapeutic safety. Inadequate bowel preparation has been reported in 10%-75% of colonoscopic examinations. For bowel preparation, laxatives such as polyethylene glycol (PEG), magnesium citrate plus picosulfate, and oral sulfate are consumed with water. During the bowel cleansing process, many bubbles are generated because a large amount of water mixed with mucus and bile. Endoscopists encounter a new obstacle -bubbles- even in the absence of stool. Polyethylene glycol (PEG), an orally-administered purgative, is recommended as the first-line bowel preparation regimen, mainly due to its effectiveness and safety. Simethicone (CH3)2 SiO, a silicone-based polymer, can disperse bubbles by decreasing surface tension. The hypothesis of this project is that addition of simethicone to low-volume PEG solution improves bowel-cleansing efficacy and compliance with shorter caecal intubation time and higher Adenoma Detection Rate.  Hence the primary objective of this study  is to compare the quality of colonoscopy bowel preparation of patients taking low volume PEG-Electrolyte solution(PEG-ELSE) with patients taking simethicone along with PEG-ELS.  Secondary Objective is to compare the visibility, caecal intubation time, withdrawal time, adenoma detection rate and incidence of adverse events in patients taking low volume PEG-ELS solution with patients taking simethicone along with PEG-ELS solution.

 
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