| 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
|
|
|
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
|
|
|
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. |