Frequency of Vertebrospinal Anomalies in Patients Presenting With Anorectal Malformations

NCT ID: NCT06234020

Last Updated: 2024-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-16

Study Completion Date

2024-07-11

Brief Summary

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To determine the frequency of different vertebrospinal anomalies in patients with ARM

Detailed Description

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106 pediatric patients presenting in Department of Neonatal and Paediatric Surgery, The Children Hospital, PIMS from date of approval up to 6 months with diagnosis of anorectal malforatioms will be enrolled in the study using non-probability convenience sampling technique. In this way, 106 patients will be included in the study. Patient selection will be made in the light of aforementioned exclusion and inclusion criteria of the study. Guardians of all patients will be explained about the study and informed consent will be obtained from them. Baseline data of enrolled patients will be recorded in the clinical questionnaire after careful history and examination. All patients born in our setup go through initial Xray of Lumbar spine and sacrum and ultrasound of spine which will be observed. Findings in the imaging will be noted in the clinical performa. It will be ensured that data is collected after approval of the synopsis and patient's confidentiality would not be breeched. Patients would have the autonomy to withdraw from study whenever they want.

Conditions

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Anorectal Malformations

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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To see the frequency of vertebrospinal anomalies in patients presenting with Anorectal Malformation

The patients presenting with anorectal malformation go through x-ray. We will get the reporting of x-ray done to see the vertebral anomalies and the patients presenting with fecal/urinary incontinence will go through MRI for spinal anomalies.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* I.Neonates and Paediatric patients from age 1 day to 12 years II.Presenting in Department of Paediatric Surgery with Anorectal Malformation III.Both Pre and Post Op

Exclusion Criteria

* Patients who have not consented for further investigations
Minimum Eligible Age

1 Day

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shaheed Zulfiqar Ali Bhutto Medical University

OTHER

Sponsor Role lead

Responsible Party

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Mansoor Ahmed

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shaheed Zulfiqar Ali Bhutto Medical University/PIMS

Islamabad, , Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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F.3-11/2023(ERRB)/Chairman

Identifier Type: -

Identifier Source: org_study_id

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