IntussusceptionNCT04454320
Seasonal Variations and Different Treatment Protocols of Intussusception in Children: Our Centers Experiences
An observational study of Intussusception, run by Minia University.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Intussusception
- What is being tested?
- INTUSSUSCEPTION IN CHILDREN
- How many people
- 470 participants
- Where
- No sites listed yet
- Study dates
- Jul 2020to Jan 2021
- 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 year to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: All pediatric patients (up to 14 years old) hospitalized with diagnosis of bowel intussusception were included in the study.
Who may be able to join
- Inclusion Criteria: The verified diagnosis of intussusceptions in patients by clinical examination and ultrasonography
Who cannot join
- Patients were excluded if the diagnosis of intussusceptions was not validated or patients who were above 12 years of age.
About this study
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.
- Conditions
- Intussusception
- Being tested
- INTUSSUSCEPTION IN CHILDREN
- Medical subject headings
- Intussusception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTUSSUSCEPTION IN CHILDRENOther
the seasonal variation and management outcomes of childhood intussusception.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study startJul 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for IntussusceptionStudies of the same condition, open and under way.
- More trials run by Minia 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 470 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa A.E. Moustafa, MD, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454320
- Sponsor's protocol ID
- intussusception in children
- Status last verified
- Jun 2020
- First submitted
- 25 Jun 2020
- Last updated
- 1 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 19418060Parashar 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seasonal Variations and Different Treatment Protocols of Intussusception in Children: Our Centers Experiences
- ClinicalTrials.gov ID
- NCT04454320
- Acronym / sponsor ID
- intussusception in children
- Conditions
- Intussusception
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 470 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- Jul 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 1 Jul 2020 (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.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All pediatric patients (up to 14 years old) hospitalized with diagnosis of bowel intussusception were included in the study.
Key inclusion criteria (1 listed)
- Inclusion Criteria: The verified diagnosis of intussusceptions in patients by clinical examination and ultrasonography
Key exclusion criteria (1 listed)
- Patients were excluded if the diagnosis of intussusceptions was not validated or patients who were above 12 years of age.
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 |
|---|---|---|
| INTUSSUSCEPTION IN CHILDRENthe seasonal variation and management outcomes of childhood intussusception. | Other | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
- Results publication: PubMed 19418060Lehnert 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.
- Results publication: PubMed 11099597Parashar 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Intussusception, run by Minia University.
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 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the seasonal variation and management outcomes of childhood intussusception. (time frame: 2 years). 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 NCT04454320, which also lists 2 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 1 Jul 2020.