NCT06234020

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 16, 2024

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2024

Completed
Last Updated

July 15, 2024

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

January 22, 2024

Last Update Submit

July 11, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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.

Eligibility Criteria

Age1 Day - 12 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting in OPD, Emergency and admitted in ward.

You may qualify if:

  • 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

You may not qualify if:

  • Patients who have not consented for further investigations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaheed Zulfiqar Ali Bhutto Medical University/PIMS

Islamabad, 44000, Pakistan

Location

MeSH Terms

Conditions

Anorectal Malformations

Condition Hierarchy (Ancestors)

Digestive System AbnormalitiesDigestive System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 22, 2024

First Posted

January 31, 2024

Study Start

January 16, 2024

Primary Completion

July 10, 2024

Study Completion

July 11, 2024

Last Updated

July 15, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Confidentiality

Locations