NCT03596320

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

July 20, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
Last Updated

July 23, 2018

Status Verified

July 1, 2018

Enrollment Period

10 months

First QC Date

July 7, 2018

Last Update Submit

July 20, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    2 year

Interventions

colonoscopyPROCEDURE

description of the results of colonoscopy im managment of children with rectal bleeding

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

all children with bleeding per rectum underwent colonoscopy

You may qualify if:

  • all children with rectal bleeding underwent colonoscopy

You may not qualify if:

  • children underwent colonoscopy rather than rectal bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut U

Asyut, Egypt

Location

Related Publications (7)

  • 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.

    PMID: 13897571BACKGROUND
  • 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.

    PMID: 19075198BACKGROUND
  • 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.

    PMID: 21083610BACKGROUND
  • 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.

    PMID: 10752017BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

Colonic Diseases

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Soha Iraqi

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeinab Mohi eldeen, Professor

CONTACT

Nagla Hassan, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

July 7, 2018

First Posted

July 23, 2018

Study Start

July 20, 2018

Primary Completion

May 30, 2019

Study Completion

July 30, 2019

Last Updated

July 23, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations