| CTRI Number |
CTRI/2023/09/057436 [Registered on: 11/09/2023] Trial Registered Prospectively |
| Last Modified On: |
18/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A randomized control trial of a brief educational intervention on colonoscopy preparation in inflammatory bowel disease |
|
Scientific Title of Study
|
A randomized control trial to assess the effectiveness of a brief educational intervention on colonoscopy preparation and experience in patients with inflammatory bowel disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vishal Sharma |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Associate Professor Room No 12 Nehru Hospital F Block
Department of Gastroenterology Postgraduate Institute of Medical Education and Research
Sector 12
Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087008099 |
| Fax |
|
| Email |
docvishalsharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vishal Sharma |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and research |
| Address |
Associate Professor
Department of Gastroenterology
Room No 12 Nehru Hospital F Block Postgraduate Institute of Medical Education and research
Sector 12
Sector 12
CHANDIGARH
160012
India |
| Phone |
7087008099 |
| Fax |
|
| Email |
docvishalsharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SUMANPREET KAUR |
| Designation |
NURSING OFFICER |
| Affiliation |
Block Postgraduate Institute of Medical Education and research |
| Address |
Nursing Officer
GEICU F BLOCK NEHRU HOSPITAL Block Postgraduate Institute of Medical Education and research SECTOR 12
Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
6280945373 |
| Fax |
|
| Email |
sumanbrar466@gmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical Education and Research, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Postgraduate Institute of Medical Education and research |
| Address |
Director, Postgraduate Institute of Medical Education and Research, Chandigarh, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Vishal Sharma |
Postgraduate Institute of Medical Education and research |
Department of Gastroenterology, Nehru Hospital, Postgraduate Institute of Medical Education and research, Sector 12
Chandigarh
CHANDIGARH |
7087008099
docvishalsharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical Education and Research, Chandigarh Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K50||Crohns disease [regional enteritis], (2) ICD-10 Condition: K51||Ulcerative colitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brief educational intervention |
Apart from the standard guidelines and preparation as done in comparator group, a brief video will be shown to the patient or one attendant in the language of their choice Hindi or Punjabi or English. The video will also be provided through WhatsApp or link to Youtube. The patient will be allowed to ask questions after the video. The video provides brief information about What is IBD, Why is colonoscopy needed in IBD, Why bowel preparation is needed for colonoscopy, What are the consequences of poor preparation, How to prepare for a colonoscopy, including diet and PEG preparation. The duration of this video is between 5-10 minutes (slight variation in time for the three languages) |
| Comparator Agent |
Standard Arm |
The preparation for colonoscopy will be as per the standard ESGE guidelines. We will suggest a low fibre diet for two days preceding the start of bowel preparation. A standard split dose preparation will be used. Polyethylene glycol (PEG) will be used. A PEG sachet of 137.15 gram will be dissolved in 2 litres of water. On the day before the procedure the patient will be advised to take 2 litres over a three-hour period in the evening 5-8 PM. On the day of the procedure, another 2 litres of preparation would be administered in the morning from 4-6 AM. The procedure would be started between 10:30 AM to 12:30 PM on the day of the procedure. The procedure will be performed under conscious sedation which means that injection Midazolam 2mg will be given to the patients before the procedure. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with inflammatory bowel disease undergoing colonoscopy for mapping of disease extent or dysplasia screening
|
|
| ExclusionCriteria |
| Details |
Contraindications for colonoscopy eg active disease precluding colonoscopy, acute obstruction
Suspected stricturing disease on previous imaging or clinical symptoms
Severe systemic illness- symptomatic heart failure, CTP -C cirrhosis, chronic kidney disease with GFR < 30
Unwilling to participate
Pregnant and breastfeeding females
Psychiatric co morbidities (clinical depression, bipolar disorder or schizophrenia)
Re procedure for a patient already randomized or already included in a trial
Patients undergone an abdominal surgery in the past related to bowel disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Adequate bowel preparation as defined using Boston bowel preparation score of 6 or more |
baseline on day of colonoscopy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Perfect bowel preparation as defined using Boston bowel preparation score of 9 |
Day Zero |
| Worsening of disease activity as per increase in SCCAI or HBI score |
14 days |
| Tolerance of bowel preparation |
Day zero |
| Satisfaction with bowel preparation |
Day zero |
Time to cecal intubation
|
zero day |
| Anxiety as assessed by GAD-7 score |
14 days |
| Tolerance of procedure |
14 days |
| Willingness to undergo colonoscopy again if needed |
14 days |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="130" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/09/2023 |
| Date of Study Completion (India) |
19/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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
|
In
this randomised trial, patients with inflammatory bowel disease who are planned
for a colonoscopy for established indication will be randomized to either
receive or not receive a brief video-based education intervention. All patients
will receive a written document in the language of their choice to explain the
colonoscopy and its need and preparation. However, half of the patients will
randomly receive a video in English / Hindi/ Punjabi which provides explanation
of the colonoscopy and need for adequate preparation. We will assess if those
who receive an educational video intervention have a better colonoscopy
preparation, and if their experience of the procedure is better than those who
do not receive the educational intervention. The trial will not entail any
additional costs, procedures, visits than are clinically indicated |