Follow-up and Steroid Treatment Results in Intussusception

NCT05640375 | Completed Phase 1

• 1 other identifier: BUTF-TAcerDemir-001
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Intussusception; steroid; methylprednisolone

Outcome Measures

Primary Outcomes (1)

• Treatment of intussusception

  Ratio of Participants with No intussusception on ultrasonography

  4 hours later

Study Arms (2)

Follow-up

NO INTERVENTION

Intussuception diagnosed, Informed consent was obtained by explaining treatment options to their families, no tenderness on abdominal examination, the duration of complaints is less than 24 hours, no findings of complication, Just IV hydration and ultrasonography is repeated 4 hours later (clinical and physical examination findings are monitored)

Single dose Steroid treatment

EXPERIMENTAL

Intussuception diagnosed, Informed consent was obtained by explaining treatment options to their families, no tenderness on abdominal examination, the duration of complaints is less than 24 hours, no findings of complication, Methylprednisolone 1 mg/ kg single dose was given and ultrasonography is repeated 4 hours later (clinical and physical examination findings are monitored)

Drug: Methylprednisolone

Interventions

Methylprednisolone DRUG

Single dose, 1 mg/kg

Also known as: Steroid

Single dose Steroid treatment

Eligibility Criteria

• Age: 1 Month - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• who applied to Başkent University Ankara Hospital Pediatric Emergency Polyclinic,
• Diagnosed with intussusception by USG,
• Consulted with Pediatric Surgery
• Informed consent was obtained by explaining treatment options to their families.

You may not qualify if:

• Diffuse tenderness and defense on abdominal examination,
• The duration of the complaints exceeds 24 hours,
• When the intestinal blood supply is decreased in the ultrasound findings,
• Patients with free air on the standing abdominal X-ray,
• Patients with pathology requiring urgent surgical intervention

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Baskent University

Ankara, 06490, Turkey (Türkiye)

Location

Related Publications (1)

• Acer-Demir T, Gultekingil A, Fakioglu E, Guney LH, Sezer R. Successful Treatment of Early Presenting Intussusception With a Single Dose of Corticosteroid: A Prospective Randomized Controlled Trial. J Pediatr Surg. 2025 Apr;60(4):162198. doi: 10.1016/j.jpedsurg.2025.162198. Epub 2025 Jan 25.

  PMID: 39914152 DERIVED

MeSH Terms

Conditions

Intussusception

Interventions

Methylprednisolone; Steroids

Condition Hierarchy (Ancestors)

Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Ender Fakıoğlu

  Baskent Univesity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 7, 2022
• Study Start: December 24, 2019
• Primary Completion: December 24, 2023
• Study Completion: December 24, 2023
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)