Frequency of Vertebrospinal Anomalies in Patients Presenting With Anorectal Malformations

Completed

• Conditions: Anorectal Malformations

• Registration Number: NCT06234020
• Lead Sponsor: Shaheed Zulfiqar Ali Bhutto Medical University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2024-01-16
• Study First Submitted: 2024-01-22
• Study First Submitted QC: 2024-01-22
• Study First Posted: 2024-01-31
• Status Verified: 2024-07
• Primary Completion: 2024-07-10
• Study Completion: 2024-07-11
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the frequency of different vertebrospinal anomalies in patients with ARM	6 months	Following anomalies will be observed in patients of Anorectal Malformation: * Normal cord; * Low lying conus; * Thickened filum terminale; * Tethered cord; * Filum cyst; * Vertebral anomalies; * Borderline conus; * Cervical rib (unilateral); * Cervical rib (bilateral); * Rudimentary 12th thoracic rib; * Absent 12th thoracic rib; * Lumbar rib; * Syrinx; * Ventriculus terminalis; * Prominent central canal

Trial Locations

Locations (1)

Shaheed Zulfiqar Ali Bhutto Medical University/PIMS; 🇵🇰 Islamabad, Pakistan