NCT04454320

Brief Summary

Intussusception remains a common cause of bowel obstruction in children and results in significant morbidity and mortality if not promptly treated. There is a paucity of prospective studies regarding childhood intussusception. This study describes the seasonal variation and management outcomes of childhood intussusception

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
470

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

July 1, 2020

Status Verified

June 1, 2020

Enrollment Period

5 months

First QC Date

June 25, 2020

Last Update Submit

June 30, 2020

Conditions

Intussusception

Outcome Measures

Primary Outcomes (1)

  • the seasonal variation and management outcomes of childhood intussusception.

    To evaluate the peak of months recorded to have cases with intussusception in 2 pediatric surgery centers across Egypt To evaluate the different modes of management of intussusception used in our centers.

    2 years

Interventions

INTUSSUSCEPTION IN CHILDRENOTHER

the seasonal variation and management outcomes of childhood intussusception.

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

All pediatric patients (up to 14 years old) hospitalized with diagnosis of bowel intussusception were included in the study.

You may not qualify if:

  • Patients were excluded if the diagnosis of intussusceptions was not validated or patients who were above 12 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Lehnert T, Sorge I, Till H, Rolle U. Intussusception in children--clinical presentation, diagnosis and management. Int J Colorectal Dis. 2009 Oct;24(10):1187-92. doi: 10.1007/s00384-009-0730-2. Epub 2009 May 6.

    PMID: 19418060RESULT

  • Parashar UD, Holman RC, Cummings KC, Staggs NW, Curns AT, Zimmerman CM, Kaufman SF, Lewis JE, Vugia DJ, Powell KE, Glass RI. Trends in intussusception-associated hospitalizations and deaths among US infants. Pediatrics. 2000 Dec;106(6):1413-21. doi: 10.1542/peds.106.6.1413.

    PMID: 11099597RESULT

MeSH Terms

Conditions

Intussusception

Condition Hierarchy (Ancestors)

Intestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 25, 2020

First Posted

July 1, 2020

Study Start

July 1, 2020

Primary Completion

December 1, 2020

Study Completion

January 1, 2021

Last Updated

July 1, 2020

Record last verified: 2020-06