- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04454320
Seasonal Variations and Different Treatment Protocols of Intussusception in Children: Our Centers Experiences
June 30, 2020 updated by: Alaa A.E. Moustafa, MD, Minia University
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Anticipated)
470
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
Inclusion Criteria:
- Inclusion Criteria: The verified diagnosis of intussusceptions in patients by clinical examination and ultrasonography
Exclusion Criteria:
- Patients were excluded if the diagnosis of intussusceptions was not validated or patients who were above 12 years of age.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the seasonal variation and management outcomes of childhood intussusception.
Time Frame: 2 years
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 1, 2020
Primary Completion (Anticipated)
December 1, 2020
Study Completion (Anticipated)
January 1, 2021
Study Registration Dates
First Submitted
June 25, 2020
First Submitted That Met QC Criteria
June 30, 2020
First Posted (Actual)
July 1, 2020
Study Record Updates
Last Update Posted (Actual)
July 1, 2020
Last Update Submitted That Met QC Criteria
June 30, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- intussusception in children
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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