NCT04316273

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

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 1, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 20, 2020

Completed
Last Updated

March 20, 2020

Status Verified

March 1, 2020

Enrollment Period

1.2 years

First QC Date

March 13, 2020

Last Update Submit

March 18, 2020

Conditions

Colonic Diseases

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

colonic surgeryOTHER

resection of duplicated colon

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients age group from 1 day till 18 years

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohammed Hamada Takrouney

Asyut, 71111, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 31285983RESULT

MeSH Terms

Conditions

Colonic Diseases

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

March 13, 2020

First Posted

March 20, 2020

Study Start

January 1, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

March 20, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

this is case report and review of literature not more than this

Locations

EG(1)