PathologyNCT04363125
Review of Isolated Hypoganglionosis and Presentation of a New Case Complicated With Sigmoid Volvulus
An observational study of Pathology and Sigmoid Volvulus, run by Dr. Ersin Arslan Education and Training Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pathology, Sigmoid Volvulus, Hypoganglionosis
- What is being tested?
- Pathology result
- How many people
- 310 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 20 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: our case of isolated hypoganglionosis and published isolated hypoganglionosis studies patients.
Who may be able to join
- isolated hypoganglionosis
- our case of isolated hypoganglionosis
Who cannot join
- hypoganglionosis with Hirschsprung's disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Ersin Arslan Training and Resource Hospital
Gaziantep
About this study
Official title: Systematic Review of Isolated Hypoganglionosis and Presentation of a New Case Complicated With Sigmoid Volvulus
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.
Read the 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.
- Conditions
- Pathology, Sigmoid Volvulus, Hypoganglionosis
- Being tested
- Pathology result
- Keywords
- colon, constipation, derotation, obstruction, Hypoganglionosis, intestinal neuronal dysplasia
- Medical subject headings
- Constipation, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pathology resultDiagnostic test
Pathology result of rectal biopsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality of sigmoid volvulus due to isolated hypoganglionosis
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start1 Jan 2019
- Primary completion1 Apr 2020
- Study completion20 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PathologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Ersin Arslan Education and Training Hospital
- Sponsor type
- Other government
- Collaborators
- Inonu University
- Responsible party
- Principal investigator, Ufuk Uylas, Dr. Ersin Arslan Education and Training Hospital
- Investigators
- ufuk uylas, Specialist, Principal investigator, Dr. Ersin Arslan Training and Resource Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363125
- Sponsor's protocol ID
- 23042020
- Status last verified
- Apr 2020
- First submitted
- 23 Apr 2020
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Review of Isolated Hypoganglionosis and Presentation of a New Case Complicated With Sigmoid Volvulus
- ClinicalTrials.gov ID
- NCT04363125
- Acronym / sponsor ID
- 23042020
- Conditions
- Pathology, Sigmoid Volvulus, Hypoganglionosis
- Keywords
- colon, constipation, derotation, obstruction, Hypoganglionosis, intestinal neuronal dysplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Dr. Ersin Arslan Education and Training HospitalOther government
- Collaborators
- Inonu University
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 20 Apr 2020 (actual)
- First posted
- 27 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- our case of isolated hypoganglionosis and published isolated hypoganglionosis studies patients.
Key inclusion criteria (2 listed)
- isolated hypoganglionosis
- our case of isolated hypoganglionosis
Key exclusion criteria (1 listed)
- hypoganglionosis with Hirschsprung's disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pathology resultPathology result of rectal biopsy | Diagnostic test | – |
Primary outcome
Mortality
Time frame: three months
Mortality of sigmoid volvulus due to isolated hypoganglionosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ufuk uylas, Specialist principal investigator
Dr. Ersin Arslan Training and Resource Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pathology and Sigmoid Volvulus, run by Dr. Ersin Arslan Education and Training Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.