Seasonal Variations and Different Treatment Protocols OF Intussusception In Children:
Primary Purpose
Intussusception
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pneumatic reduction and Laparotomy
Sponsored by
About this trial
This is an interventional treatment trial for Intussusception focused on measuring Intussusception, Pediatric surgery, Pneumoreduction
Eligibility Criteria
Inclusion Criteria:
- All patients in the pediatric age group (<14 years).
- Proved diagnosis of acute intussusception.
- Completion of patient's data in the medical records.
Exclusion Criteria:
- Other concomitant disease.
- Refused cases
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Season of presentation
Intervention
Arm Description
Comparison of number of presented cases in each season
Surgical intervention of failed Pneumatic cases is done
Outcomes
Primary Outcome Measures
Time of presentation
Seasons with high presented cases
Secondary Outcome Measures
Surgery
If we needed Invasive Intervention or Classic reduction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04486300
Brief Title
Seasonal Variations and Different Treatment Protocols OF Intussusception In Children:
Official Title
Seasonal Variations and Different Treatment Protocols OF Intussusception In Children: Our Center Experience.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 14, 2014 (Actual)
Primary Completion Date
December 13, 2018 (Actual)
Study Completion Date
March 7, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Background: 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.
METHODS: This was A prospective study of all patients admitted and treated for childhood intussusception aged < 12 year intussusception from January 2014 to December 2018 was conducted in El-Minia University Pediatric surgery unit. Data about the ages of the patients, sex, clinical presentation, duration of symptoms before presentation, mode of treatment, outcome of treatment, and incidence of recurrence were recorded and analyzed.
Detailed Description
A prospective study from January 2014 to December 2018 was conducted in 470 cases in El-Minia University Pediatric surgery unit. All pediatric patients (up to 14 years old) hospitalized with diagnosis of bowel intussusception were included in the study. The clinical records included: age, gender, signs, symptoms, and number of any previous episodes of intussusception and their treatment, concomitant pathologies and intolerance, ultrasound data, laboratory parameters and performed treatment.
An ultrasonography was performed when patients presented suspicion symptoms and signs of intussusception, in order to confirm the diagnosis and exclude other causes. Diagnosis was based on the presence of the "target sign" on vertical section on ultrasound images. Collected data included location and diameter of the intussusception, free fluid in abdomen and presence of visible pathological lead point. If diagnosis was confirmed, the management and treatment depended on the patients' situation, in patients complaining of severe dehydration, high grade fever and other signs of septicemia the conservative treatment was contraindicated and direct surgical treatment was performed. For children in good general conditions initial Pneumatic reduction under continuous imaging monitoring using a C-arm device was attempted; if reduction failed or unstable vital signs were observed, enema was discontinued and surgical management was proposed. If intussusception recurrence was observed in the next hours, Pneumatic reduction was performed again whenever possible.
Treatment After fluid and electrolyte correction, Pneumatic reduction was performed by using air through an 18 F urinary catheter applied to the rectum under continuous imaging guidance by C-arm. With child in a supine position, a Foley catheter was introduced in the rectum and maintained by inflating its balloon with 40 ml saline; the buttocks were joined with a band aid in order to avoid leaks. The rectal cannula was connected to Sphygmomanometer inflatable cuff initially about 80 mmHg increasing up to a maximum of 120. The passage of air into the ileum through the ileocecal valve ensures successful reduction. No time limit was imposed on the duration of the procedure; however, cessation of retrograde movement of the intussusception for more than 15 minutes was regarded as a failed attempt. The procedure was repeated 20 minutes later, with a maximum of 3 attempts.
All children were kept under medical supervision, no oral intake was permitted for the following 24 hours and intravenously fluids and antibiotics were given. After 12 to 24 hours ultrasonography was repeated to exclude early recurrence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intussusception
Keywords
Intussusception, Pediatric surgery, Pneumoreduction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
470 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Season of presentation
Arm Type
No Intervention
Arm Description
Comparison of number of presented cases in each season
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Surgical intervention of failed Pneumatic cases is done
Intervention Type
Procedure
Intervention Name(s)
Pneumatic reduction and Laparotomy
Intervention Description
Pneumatic reduction is the main intervention for suitable cases and If failed a laparotomy exploration and surgical reduction is done to save life
Primary Outcome Measure Information:
Title
Time of presentation
Description
Seasons with high presented cases
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Surgery
Description
If we needed Invasive Intervention or Classic reduction
Time Frame
2 Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All patients in the pediatric age group (<14 years).
Proved diagnosis of acute intussusception.
Completion of patient's data in the medical records.
Exclusion Criteria:
Other concomitant disease.
Refused cases
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
all IPD that underlie results in a publication
IPD Sharing Time Frame
data will be available for 10 years
IPD Sharing Access Criteria
open Access Journal
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Seasonal Variations and Different Treatment Protocols OF Intussusception In Children:
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