CT Images of Internal HerniaNCT03703752
CT and Clinical Features of Internal Hernia
An observational study of CT Images of Internal Hernia and Clinical Outcomes, run by Tongji Hospital at 1 site in China.
Trial summary
Researchers retrospectively reviewed patients with internal hernia that confirmed by surgical exploration between Feb. 2012 and Feb. 2018. and analysis the Medical records and MDCT images to investigate the clinical and radiological features of internal hernia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- CT Images of Internal Hernia, Clinical Outcomes
- What is being tested?
- Multi-detector CT scan
- How many people
- 51 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2018to 20 Jun 2018
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All Patients with definite diagnosis of IH during surgical exploration from Feb. 2012 to Feb. 2018 in our hospital were included in this research
Who may be able to join
- IH confirmed by surgical exploration
Who cannot join
- diaphragmatic hernia and traumatic IH
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CT Images and Clinical Relevance of Internal Hernia
Researchers retrospectively reviewed patients with internal hernia that confirmed by surgical exploration between Feb. 2012 and Feb. 2018. and analysis the Medical records and MDCT images to investigate the clinical and radiological features of internal hernia.
Read the detailed description
51 Patients with definite diagnosis of IH during surgical exploration from Feb. 2012 to Feb. 2018 in our hospital were included in this research. Medical records including MDCT images and intra-operative findings were collected retrospectively. The CT features of different subgroups were also evaluated.
- Conditions
- CT Images of Internal Hernia, Clinical Outcomes
- Being tested
- Multi-detector CT scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-detector CT scanDiagnostic test
This is a diagnostic radiological test to diagnose the IH and evaluate the clinical condition of IH
| Study group | Role | What they receive |
|---|---|---|
| Adhesive IH | Adhesive IH can further be divided into primary or secondary groups according to the history of abdominal and(or) pelvic surgery Receives: Diagnostic Test: Multi-detector CT scan | |
| non-adhesive IH | Non-adhesive IH means the IH resulting from the abnormality of peritoneal structure. Receives: Diagnostic Test: Multi-detector CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
CT features
MDCT features of IH were assessed for the following findings: (1) Demonstration of bowels dislocation in IH: dislocated cluster of the intestinal segments; crowding or convergence of mesenteric vessels; (2) Demonstration of obstruction or ischemia: bowel wall thickening or abnormal enhancement; dilated bowels with abnormal free fluid; twisted bowels with swirl sign of vessels. (3) Demonstration of specific signs: hernial orifice and closed-loop of intestine; fat notch sign.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start20 Feb 2018
- Primary completion20 Jun 2018
- Study completion20 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CT Images of Internal HerniaStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lei Dou, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703752
- Sponsor's protocol ID
- TJ-10207102
- Status last verified
- Oct 2018
- First submitted
- 9 Oct 2018
- Last updated
- 12 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT Images and Clinical Relevance of Internal Hernia
- ClinicalTrials.gov ID
- NCT03703752
- Acronym / sponsor ID
- TJ-10207102
- Conditions
- CT Images of Internal Hernia, Clinical Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 20 Jun 2018 (actual)
- Study completion
- 20 Jun 2018 (actual)
- First posted
- 12 Oct 2018 (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.
Researchers retrospectively reviewed patients with internal hernia that confirmed by surgical exploration between Feb. 2012 and Feb. 2018. and analysis the Medical records and MDCT images to investigate the clinical and radiological features of internal hernia.
Detailed description
51 Patients with definite diagnosis of IH during surgical exploration from Feb. 2012 to Feb. 2018 in our hospital were included in this research. Medical records including MDCT images and intra-operative findings were collected retrospectively. The CT features of different subgroups were also evaluated.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adhesive IH | – | Diagnostic Test: Multi-detector CT scanAdhesive IH can further be divided into primary or secondary groups according to the history of abdominal and(or) pelvic surgery |
| non-adhesive IH | – | Diagnostic Test: Multi-detector CT scanNon-adhesive IH means the IH resulting from the abnormality of peritoneal structure. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All Patients with definite diagnosis of IH during surgical exploration from Feb. 2012 to Feb. 2018 in our hospital were included in this research
Key inclusion criteria (1 listed)
- IH confirmed by surgical exploration
Key exclusion criteria (1 listed)
- diaphragmatic hernia and traumatic IH
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 |
|---|---|---|
| Multi-detector CT scanThis is a diagnostic radiological test to diagnose the IH and evaluate the clinical condition of IH | Diagnostic test | Adhesive IH, non-adhesive IH |
Primary outcome
CT features
Time frame: 2 weeks
MDCT features of IH were assessed for the following findings: (1) Demonstration of bowels dislocation in IH: dislocated cluster of the intestinal segments; crowding or convergence of mesenteric vessels; (2) Demonstration of obstruction or ischemia: bowel wall thickening or abnormal enhancement; dilated bowels with abnormal free fluid; twisted bowels with swirl sign of vessels. (3) Demonstration of specific signs: hernial orifice and closed-loop of intestine; fat notch sign.
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 12 Oct 2018.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 CT Images of Internal Hernia and Clinical Outcomes, run by Tongji Hospital at 1 site in China.
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 1 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 12 Oct 2018. 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 China. 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?
CT features (time frame: 2 weeks). 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 12 Oct 2018.