Frequency of Vertebrospinal Anomalies in Patients Presenting With Anorectal Malformations

Frequency of Vertebro-spinal Anomalies in Patients Presenting With Ano-rectal Malformations

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

Study Overview

• Status: Completed
• Conditions: Anorectal Malformations
• Intervention / Treatment: Other: To see the frequency of vertebrospinal anomalies in patients presenting with Anorectal Malformation

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 Type: Observational
• Enrollment (Actual): 106

Contacts and Locations

Study Locations

• Pakistan
  • Islamabad, Pakistan, 44000
    • Shaheed Zulfiqar Ali Bhutto Medical University/PIMS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting in OPD, Emergency and admitted in ward.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the frequency of different vertebrospinal anomalies in patients with ARM	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	6 months

Collaborators and Investigators

• Sponsor: Shaheed Zulfiqar Ali Bhutto Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2024
• Primary Completion (Actual): July 10, 2024
• Study Completion (Actual): July 11, 2024

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Actual): January 31, 2024

Study Record Updates

• Last Update Posted (Actual): July 15, 2024
• Last Update Submitted That Met QC Criteria: July 11, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Digestive System Abnormalities; Congenital Abnormalities; Anorectal Malformations
• Other Study ID Numbers: F.3-11/2023(ERRB)/Chairman

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Confidentiality

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No