NCT02691858

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 25, 2016

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

10.2 years

First QC Date

February 22, 2016

Last Update Submit

August 25, 2024

Conditions

Intussusception

Keywords

Intussusception

Outcome Measures

Primary Outcomes (1)

  • Success of Pneumatic Reduction

    Comparing number of Successful Pneumatic Reductions in both groups

    1 Hour

Secondary Outcomes (2)

  • Reducing number of trials of Pneumatic Reduction

    2 Hours

  • Reducing complications

    2 Hours

Study Arms (2)

Hydrocortisone

EXPERIMENTAL

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

Drug: Hydrocortisone

Saline

PLACEBO COMPARATOR

Saline IV 100 ml with Resuscitation before attempting reduction, single dose with Resuscitation before attempting reduction

Drug: Saline

Interventions

HydrocortisoneDRUG

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

Also known as: Solu-Cortef
Hydrocortisone
SalineDRUG

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

Also known as: sodium chloride 0.9%
Saline

Eligibility Criteria

Age3 Months - 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infantile Intussusception

You may not qualify if:

  • Peritonitis Pneumoperitoneum Morbid patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University Pediatric Hospital

Cairo, 11432, Egypt

RECRUITING

Related Publications (2)

  • Gersema, Lisa, and Karen Baker.

    BACKGROUND

  • Kara, Cüneyt Orhan, and Inci Gökalan.

    RESULT

MeSH Terms

Conditions

Intussusception

Interventions

Hydrocortisonehydrocortisone hemisuccinateSodium Chloride

Condition Hierarchy (Ancestors)

Intestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-HydroxycorticosteroidsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Gamal El Tagy, MD

    Cairo University

    STUDY CHAIR

Central Study Contacts

Mostafa Gad, MSc

CONTACT

201002265009mostafagad@kasralainy.edu.eg

Mahmoud Elfiky, MD

CONTACT

201001557755mfiky@kasralainy.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Pediatric Surgery

Study Record Dates

First Submitted

February 22, 2016

First Posted

February 25, 2016

Study Start

April 1, 2015

Primary Completion

June 1, 2025

Study Completion

December 1, 2025

Last Updated

August 27, 2024

Record last verified: 2024-08

Locations

EG(1)