Frequency of Vertebrospinal Anomalies in Patients Presenting With Anorectal Malformations

Anorectal Malformations Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06234020
• Other study ID #: F.3-11/2023(ERRB)/Chairman
• Status: Recruiting
• Start date: January 16, 2024
• Est. completion date: May 29, 2024

Study information

• Verified date: April 2024
• Source: Shaheed Zulfiqar Ali Bhutto Medical University
• Contact: Mansoor Ahmed, MBBS
• Phone: +923338333592
• Email: mansoorahmed1993[@]live.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Description:

67 pediatric patients presenting in Department of Neonatal and Paediatric Surgery, The Children Hospital, PIMS from date of approval upto 2 months with diagnosis of anorectal malforatioms will be enrolled in the study using non-probability convenience sampling technique. In this way, 67 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. Subsequently, these patients will undergo imaging through whole body X-rays and spinal cord MRI. Findings in the MRI 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 67
• Est. completion date: May 29, 2024
• Est. primary completion date: April 29, 2024
• Gender: All
• Age group: 1 Day to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorectal Malformations
• Congenital Abnormalities

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Pakistan	Shaheed Zulfiqar Ali Bhutto Medical University/PIMS	Islamabad

Sponsors (1)

Lead Sponsor	Collaborator
Shaheed Zulfiqar Ali Bhutto Medical University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 months