- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03596320
Yield of Colonoscopy in Children With Rectal Bleeding
Yield of Colonoscopy in Children With Bleeding Per Rectum Attending Gastrointestinal Endoscopic Unit In Assuit University Children Hospital
Study Overview
Detailed Description
Rectal bleeding is a source of anxiety for both children and parents and is frequently encountered clinical complaint in routine practice in pediatric patient . Lower gastrointestinal bleeding means bleeding from sites distal to the ligament of treitz and presents as rectal bleeding while passage of bright red blood from the rectum is called hematochezia.
The etiology of rectal bleeding is different in children than in adult according to age group which enables physicians to make appropriate differential diagnosis. There are several etiologies for rectal bleeding in pediatric practice ranging from mild condition requiring little or no treatment to severe and life-threating ones requiring immediate intervention. The etiologies include anal fissure, food allergy, infectious enterocolitis, Meckel'sdiverticulum, intussusceptions, volvulus, lymphonodular hyperplasia, inflammatory bowel disease, angiodysplasia, hemorrhoids, and hemolytic -uremic syndrome. Common causes of bleeding per rectum in children vary between studies . Once the bleeding is suspected to be coming from lower gastrointestinal tract it warrant an evaluation in all cases by proctosigmoidoscopy followed by colonoscopy .
Colonoscopy is the examination of choice for diagnosis and management of bleeding per rectum in children . The benefits of colonoscopy include identification of the site of bleeding regardless of the rate or presence of bleeding through visualization the entire length of the colon often include the distal ileum by possibility of endoscpic intervention and biopsy taking to make and confirm the diagnosis and follow up evaluation, so gastrointestinal endoscopy with biopsy is an essential tool for diagnosis of crohns disease and ulcerative colitis in children, as well as therapeutical intervention of colonoscopy by hemostasis, removing polyps, dilating stricture or decompressing the obstructed bowel .
Colonoscopy is considered a safe and low risk procedure. Complications of colonoscopy are rare and usually minor, as adverse effects of sedative medicine as (nausea,vomiting or allergies) can ocurr.
Bleeding after colonoscopy is usually minimal but may follow mucous biopsy or polypectomy, Perforation is very rare but it is the most serious complication of colonoscopy in children, it is usually related to polypectomy and can be successfully managed with surgical intervention. In case of infection in which cause the child will be given antibiotics.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Zeinab Mohi eldeen, Professor
- Phone Number: +020122397149
- Email: Zeenabmohielden1957@gmail.com
Study Contact Backup
- Name: Nagla Hassan, Professor
- Phone Number: +020111187227
- Email: Nhi_af@hotmail.com
Study Locations
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Assiut, Egypt
- Assiut U
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Contact:
- Zeinab Mohi eldeen, Professor
- Phone Number: +0201223971490
- Email: Zeenabmohielden1957@gmail.com
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Contact:
- Nagla Hassan
- Phone Number: +0201111872237
- Email: Nhi_af@hotmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- all children with rectal bleeding underwent colonoscopy
Exclusion Criteria:
- children underwent colonoscopy rather than rectal bleeding
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants free and recurrance of colonic disease after colonoscopy procedure
Time Frame: 2 year
|
Number of participants were monitored with recurrance of rectal bleeding and underwent colonoscopy up to 2 years
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2 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Soha Iraqi, Assiut University
Publications and helpful links
General Publications
- GELB AM, MINKOWITZ S, TRESSER M. Rectal and colonic polyps occurring in young people. N Y State J Med. 1962 Feb 15;62:513-8. No abstract available.
- Baxter NN, Goldwasser MA, Paszat LF, Saskin R, Urbach DR, Rabeneck L. Association of colonoscopy and death from colorectal cancer. Ann Intern Med. 2009 Jan 6;150(1):1-8. doi: 10.7326/0003-4819-150-1-200901060-00306. Epub 2008 Dec 15.
- Bai Y, Peng J, Gao J, Zou DW, Li ZS. Epidemiology of lower gastrointestinal bleeding in China: single-center series and systematic analysis of Chinese literature with 53,951 patients. J Gastroenterol Hepatol. 2011 Apr;26(4):678-82. doi: 10.1111/j.1440-1746.2010.06586.x.
- Fox VL. Gastrointestinal bleeding in infancy and childhood. Gastroenterol Clin North Am. 2000 Mar;29(1):37-66, v. doi: 10.1016/s0889-8553(05)70107-2.
- Ladas SD, Karamanolis G, Ben-Soussan E. Colonic gas explosion during therapeutic colonoscopy with electrocautery. World J Gastroenterol. 2007 Oct 28;13(40):5295-8. doi: 10.3748/wjg.v13.i40.5295.
- Park JH. Role of colonoscopy in the diagnosis and treatment of pediatric lower gastrointestinal disorders. Korean J Pediatr. 2010 Sep;53(9):824-9. doi: 10.3345/kjp.2010.53.9.824. Epub 2010 Sep 13.
- Zahmatkeshan M, Fallahzadeh E, Najib K, Geramizadeh B, Haghighat M, Imanieh MH. Etiology of lower gastrointestinal bleeding in children:a single center experience from southern iran. Middle East J Dig Dis. 2012 Oct;4(4):216-23.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- crbchildren
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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