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NCT Number: NCT02691858

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

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.

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Key information

Conditions

Intussusception Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Intestinal Obstruction

Age range

3 month–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University Pediatric Hospital

Cairo, 11432, Egypt

Location status: Recruiting

Location contact

Mahmoud Elfiky, MD

CONTACT

[email protected]

Mostafa Gad, MD

CONTACT

[email protected]

Mostafa Gad, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infantile Intussusception

Exclusion criteria

  • Peritonitis Pneumoperitoneum Morbid patients

Treatment and study plan

Hydrocortisone

Drug

10 mg/kg with Resuscitation before attempting pneumatic reduction, single dose with Resuscitation before attempting reduction

Other names: Solu-Cortef

Saline

Drug

100 ml with Resuscitation before attempting pneumatic reduction, single dose with Resuscitation before attempting reduction

Other names: sodium chloride 0.9%

Primary outcomes

  1. Success of Pneumatic Reduction

    Time frame: 1 Hour

    Comparing number of Successful Pneumatic Reductions in both groups

Secondary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Mahmoud Elfiky, MD

CONTACT

[email protected]

201001557755

Mostafa Gad, MSc

CONTACT

[email protected]

201002265009

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Hydrocortisone on Improving Outcome of Pneumatic Reduction of Infantile Intussusception: A Randomized Controlled Trial

Important dates

Study start
2015
Primary completion
2025
Study completion
2025
First posted
Feb 25, 2016
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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