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Effect of Hydrocortisone on Improving Outcome of Pneumatic Reduction of Infantile Intussusception

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ClinicalTrials.gov Identifier: NCT02691858
Recruitment Status : Recruiting
First Posted : February 25, 2016
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
Mahmoud El Fiky, Cairo University

Brief Summary:

Intussusception is one of the most frequent causes of acute bowel and second most common cause of acute abdominal pain in pediatric age .95 % of cases are idiopathic, the rest are either due to pathological lead point or post operative. Treatment of intussusception must start with medical resuscitation, then radiological or operative reduction of intussusception.

Our surgery team has used hydrocortisone with the medical resuscitation to improve the success rate of pneumatic reduction and decrease the number of reduction trials.


Condition or disease Intervention/treatment Phase
Intussusception Drug: Hydrocortisone Drug: Saline Not Applicable

Detailed Description:

Experimental group will be given single dose IV Hydrocortisone 10 mg/kg with Resuscitation before attempting first trial of pneumatic reduction and the outcome measured.

Control group will be given Saline 100 ml IV single injection with Resuscitation before attempting first trial of pneumatic reduction and the outcome measured.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Hydrocortisone on Improving Outcome of Pneumatic Reduction of Infantile Intussusception: A Randomized Controlled Trial
Study Start Date : April 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: Hydrocortisone
Hydrocortisone IV 10 mg/kg with Resuscitation before attempting reduction, single dose with Resuscitation before attempting reduction
Drug: Hydrocortisone
10 mg/kg with Resuscitation before attempting pneumatic reduction, single dose with Resuscitation before attempting reduction
Other Name: Solu-Cortef

Placebo Comparator: Saline
Saline IV 100 ml with Resuscitation before attempting reduction, single dose with Resuscitation before attempting reduction
Drug: Saline
100 ml with Resuscitation before attempting pneumatic reduction, single dose with Resuscitation before attempting reduction
Other Name: sodium chloride 0.9%




Primary Outcome Measures :
  1. Success of Pneumatic Reduction [ Time Frame: 1 Hour ]
    Comparing number of Successful Pneumatic Reductions in both groups


Secondary Outcome Measures :
  1. Reducing number of trials of Pneumatic Reduction [ Time Frame: 2 Hours ]
    Comparing average number of Pneumatic Reduction trials between both groups

  2. Reducing complications [ Time Frame: 2 Hours ]
    Comparing number of complications in both groups



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Ages Eligible for Study:   3 Months to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infantile Intussusception

Exclusion Criteria:

  • Peritonitis Pneumoperitoneum Morbid patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02691858


Contacts
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Contact: Mostafa Gad, MSc 201002265009 mostafagad@kasralainy.edu.eg
Contact: Mahmoud Elfiky, MD 201001557755 mfiky@kasralainy.edu.eg

Locations
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Egypt
Cairo University Pediatric Hospital Recruiting
Cairo, Egypt, 11432
Contact: Mahmoud Elfiky, MD       mfiky@kasralainy.edu.eg   
Contact: Mostafa Gad, MD       mostafagad@kasralainy.edu.eg   
Principal Investigator: Mostafa Gad, MD         
Sponsors and Collaborators
Cairo University
Investigators
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Study Chair: Gamal El Tagy, MD Cairo University

Publications of Results:
Other Publications:
Gersema, Lisa, and Karen Baker.

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Responsible Party: Mahmoud El Fiky, Lecturer of Pediatric Surgery, Cairo University
ClinicalTrials.gov Identifier: NCT02691858    
Other Study ID Numbers: CAIUNIPEDSURG-CR3
First Posted: February 25, 2016    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Mahmoud El Fiky, Cairo University:
Intussusception
Additional relevant MeSH terms:
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Intussusception
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Anti-Inflammatory Agents