NCT04363125

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
310

participants targeted

Target at P75+ 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

April 1, 2020

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 27, 2020

Completed
Last Updated

April 28, 2020

Status Verified

April 1, 2020

Enrollment Period

1.2 years

First QC Date

April 23, 2020

Last Update Submit

April 26, 2020

Conditions

Keywords

colonconstipationderotationobstructionHypoganglionosisintestinal neuronal dysplasia

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Mortality of sigmoid volvulus due to isolated hypoganglionosis

    three months

Interventions

Pathology resultDIAGNOSTIC_TEST

Pathology result of rectal biopsy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • isolated hypoganglionosis
  • our case of isolated hypoganglionosis

You may not qualify if:

  • hypoganglionosis with Hirschsprung's disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Ersin Arslan Training and Resource Hospital

Gaziantep, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ConstipationBites and Stings

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsPoisoningChemically-Induced DisordersWounds and Injuries

Study Officials

  • ufuk uylas, Specialist

    Dr. Ersin Arslan Training and Resource Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 23, 2020

First Posted

April 27, 2020

Study Start

January 1, 2019

Primary Completion

April 1, 2020

Study Completion

April 20, 2020

Last Updated

April 28, 2020

Record last verified: 2020-04

Locations