Risk Factors for Recurrent Intussusception Successful Reduction in Pediatric Patients

Intussusception Clinical Trial

Official title:

Risk Factors for Recurrent Intussusception After Successful Reduction in Pediatric Patients in a Tertiary Care Hospital of Nepal: A Prospective-Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05259670
• Other study ID #: 077/078
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: February 2022
• Source: Nepal Medical Student Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To determine risk factors associated with recurrent intussusception among pediatric patients who have undergone successful reduction at a tertiary care hospital.

Description:

This is the prospective observational study. In this study, 78 patients,age <16 years with diagnosis of intussusception between June 2019 and April 2020 who had successful reduction with either hydrostatic reduction and/or operative reduction in Teaching Hospital were enrolled in the study. They were followed up to a period of 1 month for recurrence of intussusception. The recurrent cases were thus identified and various variables were compared between recurrent and non-recurrent cases by univariable and multivariable analysis.

This prospective observational study was approved by the ethics committees of Institutional review board of Tribhuvan University, Institute of Medicine.

A standard structured questionnaire was filled by interviewing the patient (if possible) and family members/relatives after taking informed written consent. The questionnaire documented the patient's age, sex, weight, duration of symptoms, presenting symptoms: abdominal pain, excessive cry, vomiting, lethargy, blood in stool, fever, palpable mass, constipation, diarrhoea ,location of mass, enlarged lymph nodes(LNs), blood counts and methods of reduction. Age of 2 years, weight of 12 kg and duration of symptoms of 48 hours was used to classify patients into two groups

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

Inclusion Criteria:

• We included the patients who were diagnosed with intussusception from the age of 0 year to 16 years who received nonoperative and operative reduction as an initial treatment.

Exclusion Criteria:

• Pediatric patients with spontaneous reduction of hydro-reduction and who required resection and anastomosis as a part of operative procedure were excluded from the study.

Related Conditions & MeSH terms

• Intussusception

Locations

Country	Name	City	State
Nepal	Tribhuvan University Teaching hospital	Kathmandu	Bagmati
Nepal	Tribhuvan University Teaching hospital	Maharajgunj	Bagmati

Sponsors (2)

Lead Sponsor	Collaborator
Sanjeev Kharel	Tribhuvan University Teaching Hospital, Institute Of Medicine.

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk factor for recurrent intussusception	Significant risk factor for recurrent intussusception after successful reduction	June 2019-April 2020