Review of Isolated Hypoganglionosis and Presentation of a... | NCT04363125

Studies
Review of Isolated Hypoganglionosis and Presentation of a New Case Complicated With Sigmoid Volvulus

NCT04363125

Sponsor

Dr. Ersin Arslan Education and Training Hospital

Status

Completed

Last Update Posted

Apr 28, 2020Actual

Enrollment

310Actual

Phase

Not provided

Conditions

Pathology
Sigmoid Volvulus
Hypoganglionosis

Interventions

Pathology result

Countries

Turkey (Türkiye)

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

Apr 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

Apr 1, 2020Actual

Completion Date

Apr 20, 2020Actual

First Submitted Date

Apr 23, 2020

First Submission Date that Met QC Criteria

Apr 23, 2020

First Posted Date

Apr 27, 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

Apr 26, 2020

Last Update Posted Date

Apr 28, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ufuk Uylas, Principal Investigator, Dr. Ersin Arslan Education and Training HospitalPrincipal Investigator

Lead Sponsor

Dr. Ersin Arslan Education and Training HospitalOTHER_GOV

Collaborators

Name	Class
Inonu University	OTHER

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

Detailed Description

Isolated hypoganglionosis is rare and constitutes 3-5% of all congenital neurological bowel diseases. Since hypoganglionosis is associated with symptoms such as chronic constipation or pseudo-obstruction, it can be confused with Hirschprung's disease and it is important to make a differential diagnosis before treatment. Our aim in this study; In addition to sharing the rarely isolated hypoganglionosis and sigmoid volvulus in a 45-year-old male patient with mental retardation, the investigators present a systematic comprehensive review of hypoganglionosis. Pubmed and Scopus databases were scanned. No restrictions were used in the written language. Only isolated cases of hypoganglionosis were added to the study. In the cases; author, year of publication, country of publication, age, gender, surgical or non-surgical treatments, treatment results, and mortalities were examined.

When sigmoid volvulus is seen in children and adolescents, congenital neurological bowel diseases should be considered in the differential diagnosis. Hirschprung's disease must be ruled out by rectal biopsy. The histopathological investigation should be carried out for the diagnosis and determination of surgical margins in isolated hypoganglionosis.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

310Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pathology result	Diagnostic Test	Pathology result of rectal biopsy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	Mortality of sigmoid volvulus due to isolated hypoganglionosis	three months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

isolated hypoganglionosis
our case of isolated hypoganglionosis

Exclusion Criteria:

hypoganglionosis with Hirschsprung's disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

our case of isolated hypoganglionosis and published isolated hypoganglionosis studies patients.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ufuk uylas, Specialist	Dr. Ersin Arslan Training and Resource Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dr. Ersin Arslan Training and Resource Hospital		Gaziantep			Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D003248	Constipation
D001733	Bites and Stings

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D011041	Poisoning

Browse Leaves

Not provided

Browse Branches

Not provided