PathologyNCT04383249
Routine Pathological Examination of Hernia Sac; Is it a Workload or Necessary?
An observational study of Pathology, run by Dr. Ersin Arslan Education and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Routine microscopic examination of the hernia sac is controversial. While some centers do not recommend a routine microscopic examination in inguinal hernias in adult patients, they recommend them in abdominal wall hernias. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pathology
- What is being tested?
- Pathology result
- How many people
- 437 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 7 May 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
- Child, Adult, Older adult
Study population: Patients who have operated hernia and sent hernia sac for histopathological examination.
Who may be able to join
- Emergency operated patients
- Elective operated patients
Who cannot join
- Hernia repairs without pathology examinations
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Ersin Arslan Training and Resource Hospital
Gaziantep
About this study
Routine microscopic examination of the hernia sac is controversial. While some centers do not recommend a routine microscopic examination in inguinal hernias in adult patients, they recommend them in abdominal wall hernias. The investigators aimed to discuss the pathology results and unexpected histopathological findings who underwent abdominal wall and inguinal hernia operation in the light of the literature.
Read the detailed description
The hernia is defined as the passage of an organ or tissue from one anatomical region to another. Hernia sacs are sent to the pathology department, although there is a difference between clinics. Routine microscopic examination of the hernia sac is controversial. While some centers do not recommend a routine microscopic examination in inguinal hernias in adult patients, they recommend them in abdominal wall hernias. Here, the investigators aimed to discuss the pathology results and unexpected histopathological findings who underwent abdominal wall and inguinal hernia operation in the light of the literature. Patients who have operated hernia and sent hernia sac for histopathological examination were retrospectively screened. Emergency and elective operated patients were included. Hernia repairs without pathology were excluded from the study. Patients' gender, age, operation notes, and pathology results were analyzed. Pathology results were analyzed in two groups as expected findings and unexpected findings. In our study, the probability of encountering an unexpected pathological result was found to be quite low in the pathological evaluation of the hernia sac. Although it may cause additional workload and cost, all hernia sacs should be sent to routine pathological examination. The investigators believe that making savings in these areas through further investigation after the decision of the pathologist.
- Conditions
- Pathology
- Being tested
- Pathology result
- Keywords
- Hernia sac, inguinal hernia, incisional hernia, intestine, omentum
- Medical subject headings
- Hernia, Inguinal, Incisional Hernia
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 the hernia sac
| Study group | Role | What they receive |
|---|---|---|
| Pathology result | Pathology result of the hernia sac Receives: Diagnostic Test: Pathology result |
What is being measured
The primary outcome is the main question the study is designed to answer.
unexpected finding
rate of unexpected result
Measured: 2 or 3 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start1 Jan 2020
- Primary completion1 May 2020
- Study completion7 May 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
- 437 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Ersin Arslan Education and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ufuk Uylas, Dr. Ersin Arslan Education and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383249
- Sponsor's protocol ID
- 07052020
- Status last verified
- May 2020
- First submitted
- 7 May 2020
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- 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 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Pathological Examination of Hernia Sac; Is it a Workload or Necessary?
- ClinicalTrials.gov ID
- NCT04383249
- Acronym / sponsor ID
- 07052020
- Conditions
- Pathology
- Keywords
- Hernia sac, inguinal hernia, incisional hernia, intestine, omentum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 437 participants (actual)
- Lead sponsor
- Dr. Ersin Arslan Education and Training HospitalOther government
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 7 May 2020 (actual)
- First posted
- 12 May 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.
Routine microscopic examination of the hernia sac is controversial. While some centers do not recommend a routine microscopic examination in inguinal hernias in adult patients, they recommend them in abdominal wall hernias. The investigators aimed to discuss the pathology results and unexpected histopathological findings who underwent abdominal wall and inguinal hernia operation in the light of the literature.
Detailed description
The hernia is defined as the passage of an organ or tissue from one anatomical region to another. Hernia sacs are sent to the pathology department, although there is a difference between clinics. Routine microscopic examination of the hernia sac is controversial. While some centers do not recommend a routine microscopic examination in inguinal hernias in adult patients, they recommend them in abdominal wall hernias. Here, the investigators aimed to discuss the pathology results and unexpected histopathological findings who underwent abdominal wall and inguinal hernia operation in the light of the literature. Patients who have operated hernia and sent hernia sac for histopathological examination were retrospectively screened. Emergency and elective operated patients were included. Hernia repairs without pathology were excluded from the study. Patients' gender, age, operation notes, and pathology results were analyzed. Pathology results were analyzed in two groups as expected findings and unexpected findings. In our study, the probability of encountering an unexpected pathological result was found to be quite low in the pathological evaluation of the hernia sac. Although it may cause additional workload and cost, all hernia sacs should be sent to routine pathological examination. The investigators believe that making savings in these areas through further investigation after the decision of the pathologist.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pathology result | – | Diagnostic Test: Pathology resultPathology result of the hernia sac |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have operated hernia and sent hernia sac for histopathological examination.
Key inclusion criteria (2 listed)
- Emergency operated patients
- Elective operated patients
Key exclusion criteria (1 listed)
- Hernia repairs without pathology examinations
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 the hernia sac | Diagnostic test | Pathology result |
Primary outcome
unexpected finding
Time frame: 2 or 3 week
rate of unexpected result
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 May 2020.
- Individual participant dataSharing planned: No
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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.
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 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 12 May 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?
unexpected finding (time frame: 2 or 3 week). 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 May 2020.