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Yield of Colonoscopy in Children With Rectal Bleeding

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03596320
Recruitment Status : Not yet recruiting
First Posted : July 23, 2018
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
SHIraqi, Assiut University

Brief Summary:
description study of colonscopy in children with bleeding per rectum attending gastrointestinal endoscopic unit in assiut university children hospital from 2014-2019

Condition or disease Intervention/treatment
Colonic Diseases Procedure: colonoscopy

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Yield of Colonoscopy in Children With Bleeding Per Rectum Attending Gastrointestinal Endoscopic Unit In Assuit University Children Hospital
Estimated Study Start Date : July 20, 2018
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : July 30, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: colonoscopy
    description of the results of colonoscopy im managment of children with rectal bleeding


Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
all children with bleeding per rectum underwent colonoscopy
Criteria

Inclusion Criteria:

  • all children with rectal bleeding underwent colonoscopy

Exclusion Criteria:

  • children underwent colonoscopy rather than rectal bleeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03596320


Contacts
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Contact: Zeinab Mohi eldeen, Professor +020122397149 Zeenabmohielden1957@gmail.com
Contact: Nagla Hassan, Professor +020111187227 Nhi_af@hotmail.com

Locations
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Egypt
Assiut U
Assiut, Egypt
Contact: Zeinab Mohi eldeen, Professor    +0201223971490    Zeenabmohielden1957@gmail.com   
Contact: Nagla Hassan    +0201111872237    Nhi_af@hotmail.com   
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Soha Iraqi Assiut University

Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: SHIraqi, principle investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03596320    
Other Study ID Numbers: crbchildren
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases