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Follow-up and Steroid Treatment Results in Intussusception

NCT05640375 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2025-02-05

No results posted yet for this study

Summary

Treatment interventions in the treatment of intussusception are hydrostatic or pneumatic reduction and manual reduction with laparotomy. In addition, it is known that in some of the ileoileal intussusception cases, intussusception disappears in short-term observation and it is an accepted treatment to follow-up for a while in ileoileal cases without making a decision for laparotomy. In a study the investigators conducted, they reported that 17 of 81 patients had spontaneous opening with follow-up and no further treatment was required. The hydrostatic or pneumatic reduction has a 0.8% risk of bowel perforation, fever due to bacterial translocation is common, septicemia has also been reported and anal fissures due to catheterization is seen. Baby or child's stress, psychology, abdominal pain are other negative aspects that cannot be measured. In a study that was reported a patient with HSP was diagnosed with intussusception while under steroid treatment, and when the patient was taken to laparoscopy, it was observed that the patient's intussusception was opened. In the same study, the authors mentioned that they followed up 4 patients diagnosed with HSP by administering only steroid treatment and observed that intussusception was opened in 3 of these patients without the need for any other intervention.

The steroid is used as a single dose (1 mg/kg) in cases such as acute allergic reactions, bronchiolitis, asthma, laryngitis, edema treatment, bronchoscopy, intubation, extubation medication. When the literature is reviewed, it has been shown that single-dose, low-amount (1 mg/kg) steroid therapy does not have side effects. The investigators predict that the steroid will reduce the thickening of Peyer's plaques with its anti-inflammatory effect, and relieve edema as in other areas of use, by relieving the congested intussusceptum. Thus, in infants and children, there will be no need for hydrostatic or pneumatic reduction, which has the risk of perforation and infection (septicemia) and exposure to radiation, and our patients will regain their health without the need to apply this interventional treatment.

Conditions

  • Intussusception

Interventions

DRUG

Methylprednisolone

Single dose, 1 mg/kg

Sponsors & Collaborators

  • Baskent University

    lead OTHER

Principal Investigators

  • Ender Fakıoğlu · Baskent Univesity

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-24
Primary Completion
2023-12-24
Completion
2023-12-24

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05640375 on ClinicalTrials.gov