Ignite Creation Date:
2024-05-06 @ 12:19 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03731806
Status:
WITHDRAWN
Last Update Posted:
2021-08-23
First Post:
2018-10-25
Brief Title:
Capsule Endoscopy in Newly Diagnosed Patients of Celiac Disease
Sponsor:
Tazeen Rasheed
Organization:
Dow University of Health Sciences
Study Overview
Official Title:
Extent of Small Bowel Involvement on Capsule Endoscopy in Newly Diagnosed Patients of Celiac Disease
Status:
WITHDRAWN
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
funding for capsule could not be secured
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Celiac Disease is an autoimmune disorder that affects approximately 1 of the worlds population 1 The diagnosis of CD requires clinical histopathological and serological factors 2 Since upper gastrointestinal endoscopy allows only visualization of the small bowel up to the second part of duodenum therefore this study was designed to determine involvement of different segments of small bowel using endoscopic scale by Bonatto MW et al 3 in newly diagnosed patients of celiac disease
Detailed Description:
This cross sectional observational study will take place in Medical Unit-II Ruth KM Pfau Civil Hospital Karachi Pakistan All newly diagnosed patients of celiac disease between the ages of 8 60 years and patients who are currently not on gluten free diet will be included
Patients having intestinal obstruction strictures fistulae dysphagia pregnant females will be excluded Patients having cardiac pacemakers or other implanted electromedical devices and those who are unable to swallow the capsule will also be excluded
All patients meeting inclusion criteria will be included Informed consent will be taken from ethics committee Patients will be provided proper brief information of procedure and confidentiality of the patients will be ensured Patients will be advised to start clear liquid diet for 24 hours before the procedure They will be advised to drink Movcol powder 10 sachet in 500ml of water within 20 mins 12 hours before the procedure They will be kept nil orally for 08 hours before the procedure Syrup Infacol simethicone 15ml diluted in 50 ml of water will be given 30 mins before the procedure Patients will be asked to swallow the capsule with 200 ml of water Patients will be allowed to take food 4 after ingestion of capsule All patients will be provided with capsule retrieval kit from stool Patients will be explained to pass any stool after ingestion of capsule till it passed in stool or up to 7 days whichever is earlier Capsule retrieved will be brought back to investigators for data retrieval from capsule Reporting will be done by person trained to interpret capsule endoscopy This will include presence of any pathology its severity approximate length and segment of small intestine involved and quality of bowel preparation
Categorical data will be presented as frequency and percentage eg gender findings of capsule endoscopy like bowel preparation mosaic patternulcers erythema telangiectasia etc Quantitative data will be presented as mean with standard deviation eg age Involvement of different segments of small intestine duodenum jejunum and Ileum will be documented Categorical data will be compared on gender by Chi-square test and quantitative data will be analyzed by students t-test Significance level will be set at 005
Patients having intestinal obstruction strictures fistulae dysphagia pregnant females will be excluded Patients having cardiac pacemakers or other implanted electromedical devices and those who are unable to swallow the capsule will also be excluded
All patients meeting inclusion criteria will be included Informed consent will be taken from ethics committee Patients will be provided proper brief information of procedure and confidentiality of the patients will be ensured Patients will be advised to start clear liquid diet for 24 hours before the procedure They will be advised to drink Movcol powder 10 sachet in 500ml of water within 20 mins 12 hours before the procedure They will be kept nil orally for 08 hours before the procedure Syrup Infacol simethicone 15ml diluted in 50 ml of water will be given 30 mins before the procedure Patients will be asked to swallow the capsule with 200 ml of water Patients will be allowed to take food 4 after ingestion of capsule All patients will be provided with capsule retrieval kit from stool Patients will be explained to pass any stool after ingestion of capsule till it passed in stool or up to 7 days whichever is earlier Capsule retrieved will be brought back to investigators for data retrieval from capsule Reporting will be done by person trained to interpret capsule endoscopy This will include presence of any pathology its severity approximate length and segment of small intestine involved and quality of bowel preparation
Categorical data will be presented as frequency and percentage eg gender findings of capsule endoscopy like bowel preparation mosaic patternulcers erythema telangiectasia etc Quantitative data will be presented as mean with standard deviation eg age Involvement of different segments of small intestine duodenum jejunum and Ileum will be documented Categorical data will be compared on gender by Chi-square test and quantitative data will be analyzed by students t-test Significance level will be set at 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None