Anorectal MalformationsNCT06234020
Frequency of Vertebrospinal Anomalies in Patients Presenting With Anorectal Malformations
An observational study of Anorectal Malformations, run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.
Trial summary
To determine the frequency of different vertebrospinal anomalies in patients with ARM Read more about this study
- Who is it for?
- Ages 1 day to 12 years
- Conditions the study is for
- Anorectal Malformations
- What is being tested?
- To see the frequency of vertebrospinal anomalies in patients presenting with Anorectal Malformation
- How many people
- 106 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Jan 2024to 11 Jul 2024
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 12 years
- All sexes
- Child
Study population: Patients presenting in OPD, Emergency and admitted in ward.
Who may be able to join
- 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
Who cannot join
- Patients who have not consented for further investigations
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Shaheed Zulfiqar Ali Bhutto Medical University/PIMS
Islamabad, 44000
About this study
Official title: Frequency of Vertebro-spinal Anomalies in Patients Presenting With Ano-rectal Malformations
To determine the frequency of different vertebrospinal anomalies in patients with ARM
Read the 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.
- Conditions
- Anorectal Malformations
- Being tested
- To see the frequency of vertebrospinal anomalies in patients presenting with Anorectal Malformation
- Medical subject headings
- Anorectal Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To see the frequency of vertebrospinal anomalies in patients presenting with Anorectal MalformationOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start16 Jan 2024
- Primary completion10 Jul 2024
- Study completion11 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorectal MalformationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mansoor Ahmed, Shaheed Zulfiqar Ali Bhutto Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234020
- Sponsor's protocol ID
- F.3-11/2023(ERRB)/Chairman
- Status last verified
- Jul 2024
- First submitted
- 22 Jan 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Vertebro-spinal Anomalies in Patients Presenting With Ano-rectal Malformations
- ClinicalTrials.gov ID
- NCT06234020
- Acronym / sponsor ID
- F.3-11/2023(ERRB)/Chairman
- Conditions
- Anorectal Malformations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical UniversityUniversity, hospital or other
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 11 Jul 2024 (actual)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the frequency of different vertebrospinal anomalies in patients with ARM
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
Who may qualify
- Ages
- 1 day to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- Patients presenting in OPD, Emergency and admitted in ward.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who have not consented for further investigations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| To see the frequency of vertebrospinal anomalies in patients presenting with Anorectal MalformationThe 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. | Other | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Individual participant dataSharing planned: No. Confidentiality
Related trials for Anorectal Malformations
Not yet recruiting
Comparison of a New Non-invasive Device With the Invasive Gold-standard Investigation to Assess Function of the Large Bowel in Children
Bowel Dysfunction, Dysmotility
Not yet recruiting
Effectiveness of Electrical Stimulation and Biofeedback on Fecal Incontinence in Children With Repaired Anorectal Malformation
Fecal Incontinence (FI), Anorectal Malformations
Recruiting
Oral Antibiotics vs. No Antibiotics in Pediatric Colorectal Surgery
Bowel Cleansing Prior to Clinical Procedures, Colorectal Anastomosis
Enrolling by invitationObservational study
Long-Term Health Outcomes in Children Born With Hirschsprung's Disease and Anorectal Malformations at the Colorectal Centre of Excellence in Quebec
Anorectal Malformation, Hirschprung's Disease
RecruitingObservational study
Outcomes in ARMs: Comparison Between Surgical Techniques in Patients With Perineal or Vestibular Fistula - a Multicenter Italian Study
Anorectal Malformations
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorectal Malformations, run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the frequency of different vertebrospinal anomalies in patients with ARM (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.