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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
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intussusception focused on measuring Intussusception, Pediatric surgery, Pneumoreduction

Eligibility Criteria

18 Months - 14 Years (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    June 28, 2020
    Last Updated
    July 22, 2020
    Sponsor
    Minia University
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    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

    Learn more about this trial

    Seasonal Variations and Different Treatment Protocols OF Intussusception In Children:

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