PathologyNCT04360525
Different Clinicopathological Features of Non-Elderly Sigmoid Volvulus Patients
An observational study of Pathology, run by Dr. Ersin Arslan Education and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Sigmoid volvulus is frequently seen in male patients over 60 years old. In the sigmoid volvulus <60 age groups, the male/female ratio is close to each other. If sigmoid volvulus develops in <60 age groups, it is more likely to be another underlying organic pathology. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pathology
- What is being tested?
- Reasons
- How many people
- 134 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 18 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: Patients who were treated for the sigmoid volvulus between 2009 and 2018 at Inonu University General Surgery Clinic.
Who may be able to join
- Sigmoid volvulus patients under the age of 60
- Sigmoid volvulus patients at the age of ≥60
Who cannot join
- Lack of data
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Ersin Arslan Training and Resource Hospital
Gaziantep
About this study
Sigmoid volvulus is frequently seen in male patients over 60 years old. In the sigmoid volvulus <60 age groups, the male/female ratio is close to each other. If sigmoid volvulus develops in <60 age groups, it is more likely to be another underlying organic pathology.
Read the detailed description
Sigmoid volvulus is frequently seen in male patients over 60 years old. Here, the investigators aimed to investigate the causes of sigmoid volvulus developing in patients under 60 years of age. Patients diagnosed with sigmoid volvulus between 2009 and 2018 were retrospectively screened. The patients were divided into two as under 60 years old and above. The co-morbidity, mortality, morbidity, complications, age and gender data of the patients were analyzed. In the sigmoid volvulus <60 age groups, the male/female ratio is close to each other. If sigmoid volvulus develops in <60 age groups, it is more likely to be another underlying organic pathology.
- Conditions
- Pathology
- Being tested
- Reasons
- Keywords
- dolichocolon, volvulus, sigmoid, Parkinson, mental retardation, Hirschsprung's disease
- Medical subject headings
- Intestinal Volvulus, Intellectual Disability, Hirschsprung Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReasonsOther
Causes of sigmoid volvulus
| Study group | Role | What they receive |
|---|---|---|
| Elderly patients | Elderly patients (60≤ age) with sigmoid volvulus Receives: Other: Reasons | |
| Young patients | Young patients (<60 age) with sigmoid volvulus Receives: Other: Reasons |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Elderly and young patients mortality
Measured: up to three months
Morbidity
Elderly and young patients morbidity
Measured: up to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Jan 2020
- Primary completion1 Apr 2020
- Study completion18 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 134 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
- NCT04360525
- Sponsor's protocol ID
- 18042020
- Status last verified
- Apr 2020
- First submitted
- 18 Apr 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Clinicopathological Features of Non-Elderly Sigmoid Volvulus Patients
- ClinicalTrials.gov ID
- NCT04360525
- Acronym / sponsor ID
- 18042020
- Conditions
- Pathology
- Keywords
- dolichocolon, volvulus, sigmoid, Parkinson, mental retardation, Hirschsprung's disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Dr. Ersin Arslan Education and Training HospitalOther government
- Collaborators
- Inonu University
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 18 Apr 2020 (actual)
- First posted
- 24 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.
Sigmoid volvulus is frequently seen in male patients over 60 years old. In the sigmoid volvulus <60 age groups, the male/female ratio is close to each other. If sigmoid volvulus develops in <60 age groups, it is more likely to be another underlying organic pathology.
Detailed description
Sigmoid volvulus is frequently seen in male patients over 60 years old. Here, the investigators aimed to investigate the causes of sigmoid volvulus developing in patients under 60 years of age. Patients diagnosed with sigmoid volvulus between 2009 and 2018 were retrospectively screened. The patients were divided into two as under 60 years old and above. The co-morbidity, mortality, morbidity, complications, age and gender data of the patients were analyzed. In the sigmoid volvulus <60 age groups, the male/female ratio is close to each other. If sigmoid volvulus develops in <60 age groups, it is more likely to be another underlying organic pathology.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elderly patients | – | Other: ReasonsElderly patients (60≤ age) with sigmoid volvulus |
| Young patients | – | Other: ReasonsYoung patients (<60 age) with sigmoid volvulus |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who were treated for the sigmoid volvulus between 2009 and 2018 at Inonu University General Surgery Clinic.
Key inclusion criteria (2 listed)
- Sigmoid volvulus patients under the age of 60
- Sigmoid volvulus patients at the age of ≥60
Key exclusion criteria (1 listed)
- Lack of data
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 |
|---|---|---|
| ReasonsCauses of sigmoid volvulus | Other | Elderly patients, Young patients |
Primary outcome
Mortality
Time frame: up to three months
Elderly and young patients mortality
Morbidity
Time frame: up to three months
Elderly and young patients morbidity
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 24 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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, 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 24 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: up to three months). The study lists 2 primary outcomes in all. 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 24 Apr 2020.