Frequency of Vertebrospinal Anomalies in Patients Presenting With Anorectal Malformations

April 16, 2024 updated by: Mansoor Ahmed, Shaheed Zulfiqar Ali Bhutto Medical University

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

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

67

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 2 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
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaheed Zulfiqar Ali Bhutto Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2024

Primary Completion (Estimated)

April 29, 2024

Study Completion (Estimated)

May 29, 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)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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