Colonic DiseasesNCT04316273
Colonic Duplication; Two Cases Report and Review of Literature
An observational study of Colonic Diseases, run by Assiut University at 1 site in Egypt.
Trial summary
Duplicated colon appendix are infrequent detected during surgical exploration. For Diagnosed cases, excision of the duplicated part is indispensable, due to risk of malignancy. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Colonic Diseases
- What is being tested?
- colonic surgery
- How many people
- 2 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Mar 2020
- How long will I take part?
- 1 Year
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients age group from 1 day till 18 years
Who may be able to join
- Pediatric patients till age of 18 years old
- All patients diagnosed with duplicated colon with or without symptoms
- Patients with duplicated colon and other associated colorectal anomalies
Who cannot join
- Patients > 18 years with duplicated colon
- All patients with duplication cyst
Trial locations and contacts
1 site in 1 country.
About this study
Duplicated colon appendix are infrequent detected during surgical exploration. For Diagnosed cases, excision of the duplicated part is indispensable, due to risk of malignancy.
Read the detailed description
Alimentary tract duplication represents(ATD) 0.2% of all pediatric congenital malformations Which affect all gastrointestinal tracts (GIT) from the mouth to the anus.
ATD more common in with no familial or racial predilection. The ileum is the most common site (30%-35%) and the colon is the least common site (7%-20%).
The transverse colon is the most common site for colonic duplication. The duplicated part of GIT maybe in the mesenteric or anti-mesenteric side. It may has same vascular supply and mesentry or not(reported only in small bowel)..
Communication between the anomalous and actual enteric lumens may or may not be present.
Here in, two cases of colonic and anal duplication add to the knowledge with review of literature of duplicated colon in children.
- Conditions
- Colonic Diseases
- Being tested
- colonic surgery
- Medical subject headings
- Colonic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colonic surgeryOther
resection of duplicated colon
What is being measured
The primary outcome is the main question the study is designed to answer.
Post duplicated colon resection constipation by Bristol stool scale
Bristol stool form scale it range from type 1 (separate hard lumps,like hard nuts) to type 7 stool (Watery, no solid pieces ENTIRELY LIQUID)
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 posted20 Mar 2020
- Study start1 Jan 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colonic DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 2 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Hamada Takrouney, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316273
- Sponsor's protocol ID
- IRB approval number:17300179
- Status last verified
- Mar 2020
- First submitted
- 13 Mar 2020
- Last updated
- 20 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: this is case report and review of literature not more than this
Publications
AbouZeid AA, Mohammad SA, Ibrahim SE, Fagelnor A, Zaki A. Late Diagnosis of Complete Colonic and Rectal Duplication in a Girl with an Anorectal Malformation. European J Pediatr Surg Rep. 2019 Jan;7(1):e47-e50. doi: 10.1055/s-0039-1692193. Epub 2019 Jul 5.
PubMed 31285983
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colonic Duplication; Two Cases Report and Review of Literature
- ClinicalTrials.gov ID
- NCT04316273
- Acronym / sponsor ID
- IRB approval number:17300179
- Conditions
- Colonic Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 20 Mar 2020 (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.
Duplicated colon appendix are infrequent detected during surgical exploration. For Diagnosed cases, excision of the duplicated part is indispensable, due to risk of malignancy.
Detailed description
Alimentary tract duplication represents(ATD) 0.2% of all pediatric congenital malformations Which affect all gastrointestinal tracts (GIT) from the mouth to the anus.
ATD more common in with no familial or racial predilection. The ileum is the most common site (30%-35%) and the colon is the least common site (7%-20%).
The transverse colon is the most common site for colonic duplication. The duplicated part of GIT maybe in the mesenteric or anti-mesenteric side. It may has same vascular supply and mesentry or not(reported only in small bowel)..
Communication between the anomalous and actual enteric lumens may or may not be present.
Here in, two cases of colonic and anal duplication add to the knowledge with review of literature of duplicated colon in children.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients age group from 1 day till 18 years
Key inclusion criteria (3 listed)
- Pediatric patients till age of 18 years old
- All patients diagnosed with duplicated colon with or without symptoms
- Patients with duplicated colon and other associated colorectal anomalies
Key exclusion criteria (2 listed)
- Patients > 18 years with duplicated colon
- All patients with duplication cyst
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 |
|---|---|---|
| colonic surgeryresection of duplicated colon | Other | – |
Primary outcome
Post duplicated colon resection constipation by Bristol stool scale
Time frame: 6 months
Bristol stool form scale it range from type 1 (separate hard lumps,like hard nuts) to type 7 stool (Watery, no solid pieces ENTIRELY LIQUID)
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 20 Mar 2020.
- Results publication: PubMed 31285983AbouZeid AA, Mohammad SA, Ibrahim SE, Fagelnor A, Zaki A. Late Diagnosis of Complete Colonic and Rectal Duplication in a Girl with an Anorectal Malformation. European J Pediatr Surg Rep. 2019 Jan;7(1):e47-e50. doi: 10.1055/s-0039-1692193. Epub 2019 Jul 5.
- Individual participant dataSharing planned: No. this is case report and review of literature not more than this
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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 Colonic Diseases, run by Assiut University at 1 site in Egypt.
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 3 inclusion and 2 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 20 Mar 2020. 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 Egypt. 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?
Post duplicated colon resection constipation by Bristol stool scale (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04316273, which also lists 1 linked publication.
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 20 Mar 2020.