Colonic Duplication; Two Cases Report and Review of Liter... | NCT04316273

Studies
Colonic Duplication; Two Cases Report and Review of Literature

NCT04316273

Sponsor

Assiut University

Status

Completed

Last Update Posted

Mar 20, 2020Actual

Enrollment

2Actual

Phase

Not provided

Conditions

Colonic Diseases

Interventions

colonic surgery

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Mar 1, 2020Actual

Completion Date

Mar 1, 2020Actual

First Submitted Date

Mar 13, 2020

First Submission Date that Met QC Criteria

Mar 18, 2020

First Posted Date

Mar 20, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2020

Last Update Posted Date

Mar 20, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Name	Type	Description	Arm Group Labels	Other Names
colonic surgery	Other	resection of duplicated colon

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients > 18 years with duplicated colon
All patients with duplication cyst

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Pediatric patients age group from 1 day till 18 years

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mohammed Hamada Takrouney		Asyut		71111	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31285983	Result	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.

ID	Term
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases