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Status unknownNCT04454320Updated Jul 1, 2020

Seasonal Variations and Different Treatment Protocols of Intussusception in Children: Our Centers Experiences

An observational study in Intussusception, sponsored by Minia University. Status unknown. Open to participants aged 1 Year to 12 Years. Per ClinicalTrials.gov, last updated 2020-07-01.

Sponsored by Minia University · Observational

The sponsor has not verified this record recently (last verified Jun 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
470
Ages
1 Year to 12 Years
Sex
All
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Study 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

Read the detailed description

Intussusception is the invagination of a segment of bowel into an adjacent segment resulting into an intestinal obstruction. It is the most common acquired cause of intestinal obstruction in children aged four months to two years with a peak of incidence between four and nine months of age. Etiology of intussusception is reported to be idiopathic in about 90% of cases and rarely is it associated with pathological lead points such as Meckel's diverticulum, appendix, solid bowel lesions, intestinal polyp, and intestinal lymphoma. It is an occlusive-strangulation type of intestinal obstruction, and all necessary measures should be taken early to ensure prompt diagnosis and treatment to avoid ischaemia and necrosis of bowel. The term comes from two Latin words, intus, which means "inside" and suscipere, which means "to receive". It has been reported in neonates and adults . The ancient Greeks, treated intestinal obstruction with enema or insufflations of air into the anus. Abdominal pain, vomiting and blood in stools are the classic triad and are uncommon and seen in less than one-third of the children affected. Cases often present with non-specific symptoms, including vomiting, pain, irritability, decreased appetite and lethargy, and this may render diagnosis of intussusception difficult. Abdominal ultrasound is considered the standard choice for its diagnosis. Non-surgical management with Pneumatic reduction (PR) by air, hydrostatic reduction by saline or contrast enema is the best procedure.Surgical management by exploratory laparotomy with simple reduction while some cases may require a bowel resection and reanastomosis for gangrenous bowel.

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Conditions studied

  • Intussusception

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03

In context

Intussusception

31 studies on the registry are indexed under Intussusception; 6 are open to participants now.

This study's planned enrollment of 470 is above the median of 250 across 15 observational studies indexed under Intussusception.

Browse Intussusception studies →

Lead sponsor

Minia University is the lead sponsor of 370 studies on the registry; 117 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Year to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Inclusion Criteria: The verified diagnosis of intussusceptions in patients by clinical examination and ultrasonography

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
470 participants (estimated)
Patient registry
No

Interventions

  • OtherINTUSSUSCEPTION IN CHILDREN

    the seasonal variation and management outcomes of childhood intussusception.

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What researchers measure

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.

    Time frame: 2 years

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 19418060 ↗
  • 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. PubMed 11099597 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jul 2020; primary completion for Dec 2020, 5 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 25, 2020
First posted
Jul 1, 2020
StartEst.
Jul 2020
Primary completionEst.
Dec 2020
CompletionEst.
Jan 2021
Last update
Jul 1, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04454320
Lead sponsor
Minia University
Responsible party
Alaa A.E. Moustafa, MD (Principal Investigator, Minia University) — Principal investigator
First posted
Jul 1, 2020
Start date
Jul 2020 (estimated)
Primary completion
Dec 2020 (estimated)
Completion
Jan 2021 (estimated)
Last update
Jul 1, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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