Frequency of Vertebrospinal Anomalies i… | Clinical Trial

Key information

Conditions

Anorectal Malformations Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases

Age range

1 day–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shaheed Zulfiqar Ali Bhutto Medical University/PIMS

Islamabad, 44000, Pakistan

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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.

Primary outcomes

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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Shaheed Zulfiqar Ali Bhutto Medical University

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Jan 31, 2024
Registry last updated: Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed