UMIN-CTR Clinical Trial

Basic information
Public title	A Case Report of complete appendiceal duplication on the normal site of a single caecum: A new variant.
Acronym	Duplex Appendix
Scientific Title	A Case Report of complete appendiceal duplication on the normal site of a single caecum: A new variant.
Scientific Title:Acronym	Duplex Appendix
Region	Africa

Condition
Condition	Duplicated Appendix in Imperforate anus
Classification by specialty	Surgery in general Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Case Report on new variant in child with congenital anomalies
Basic objectives2	Others
Basic objectives -Others	Pathologic Clasification
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To describe the newly discovered pathologic variant of duplicated appendix
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	12 months-old >
Gender	Female
Key inclusion criteria	Case Report. The patient in the study is the only one in the study
Key exclusion criteria	Not Applicable. Case Report
Target sample size	1

Research contact person
Name of lead principal investigator	1st name Allan Middle name Last name Ngulube
Organization	Midlands State University
Division name	Surgery
Zip code	+263
Address	Private Bage 9055 Gweru Zimbabwe
TEL	+263773364652
Email	drngulube@gmail.com

Public contact
Name of contact person	1st name Allan Middle name Last name Ngulube
Organization	Midlands State University
Division name	Surgery
Zip code	+263
Address	Private Bag 9055 Gweru Zimbabwe
TEL	+263773364652
Homepage URL
Email	drngulube@gmail.com

Sponsor
Institute	Mpilo Central Hospital
Institute
Department

Funding Source
Organization	No funding for this study
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Not Applicable
Address	Not Applicable
Tel	Not Applicable
Email	Not Applicable

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	Mpilo Central Hospital, Bulawayo Zimbabwe

Other administrative information
Date of disclosure of the study information	2020 Year 05 Month 26 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	1
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 05 Month 16 Day
Date of IRB	2020 Year 05 Month 26 Day
Anticipated trial start date	2020 Year 05 Month 17 Day
Last follow-up date	2020 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This is a case report of a patient with imperforate anus who had a colostomy and was noted during the surgery to have a duplicate appendix

Management information
Registered date	2020 Year 05 Month 26 Day
Last modified on	2020 Year 05 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046249