Colonic DiseasesNCT03596320
Yield of Colonoscopy in Children With Rectal Bleeding
An observational study of Colonic Diseases, run by Assiut University at 1 site in Egypt.
Trial summary
description study of colonscopy in children with bleeding per rectum attending gastrointestinal endoscopic unit in assiut university children hospital from 2014-2019 Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Colonic Diseases
- What is being tested?
- colonoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jul 2018to 30 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: all children with bleeding per rectum underwent colonoscopy
Who may be able to join
- all children with rectal bleeding underwent colonoscopy
Who cannot join
- children underwent colonoscopy rather than rectal bleeding
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut U
Asyut
Zeinab Mohi eldeen, Professor, +0201223971490, Zeenabmohielden1957@gmail.com
Nagla Hassan, +0201111872237, Nhi_af@hotmail.com
About this study
Official title: Yield of Colonoscopy in Children With Bleeding Per Rectum Attending Gastrointestinal Endoscopic Unit In Assuit University Children Hospital
description study of colonscopy in children with bleeding per rectum attending gastrointestinal endoscopic unit in assiut university children hospital from 2014-2019
Read the 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.
- Conditions
- Colonic Diseases
- Being tested
- colonoscopy
- Medical subject headings
- Colonic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colonoscopyProcedure or surgery
description of the results of colonoscopy im managment of children with rectal bleeding
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants free and recurrance of colonic disease after colonoscopy procedure
Number of participants were monitored with recurrance of rectal bleeding and underwent colonoscopy up to 2 years
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start20 Jul 2018 (estimated)
- Primary completion30 May 2019 (estimated)
- Study completion30 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Colonic DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SHIraqi, Assiut University
- Investigators
- Soha Iraqi, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596320
- Sponsor's protocol ID
- crbchildren
- Status last verified
- Jul 2018
- First submitted
- 7 Jul 2018
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 13897571Baxter 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.
PubMed 19075198Bai 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.
PubMed 21083610Fox 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.
PubMed 10752017Ladas 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.
PubMed 17879396Park 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.
PubMed 21189966Zahmatkeshan 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.
PubMed 24829660
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yield of Colonoscopy in Children With Bleeding Per Rectum Attending Gastrointestinal Endoscopic Unit In Assuit University Children Hospital
- ClinicalTrials.gov ID
- NCT03596320
- Acronym / sponsor ID
- crbchildren
- Conditions
- Colonic Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Jul 2018 (estimated)
- Primary completion
- 30 May 2019 (estimated)
- Study completion
- 30 Jul 2019 (estimated)
- First posted
- 23 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
description study of colonscopy in children with bleeding per rectum attending gastrointestinal endoscopic unit in assiut university children hospital from 2014-2019
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- all children with bleeding per rectum underwent colonoscopy
Key inclusion criteria (1 listed)
- all children with rectal bleeding underwent colonoscopy
Key exclusion criteria (1 listed)
- children underwent colonoscopy rather than rectal bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colonoscopydescription of the results of colonoscopy im managment of children with rectal bleeding | Procedure or surgery | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
- Background: PubMed 13897571GELB 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.
- Background: PubMed 19075198Baxter 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.
- Background: PubMed 21083610Bai 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.
- Background: PubMed 10752017Fox 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.
- Results publication: PubMed 17879396Ladas 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.
- Results publication: PubMed 21189966Park 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.
- Results publication: PubMed 24829660Zahmatkeshan 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.
- Ting wu C, Chen C. Characteristics and diagnostic yield of pediatric colonoscopy in Taiwan, Pediatric of neonatology 2015; 56(5): 334-8Link provided by the sponsor.
- Tringali A,Balassone V,Angelis P.Complication in pediatric colonoscopy.2015;30(5):825-39.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soha Iraqi principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonic Diseases, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zeinab Mohi eldeen, Professor (+020122397149, Zeenabmohielden1957@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants free and recurrance of colonic disease after colonoscopy procedure (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03596320, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2018.