Incisional HerniaNCT05991024
Pulmonary Ventilation Function Between Patients With Primary and Recurrent Incisional Hernia: a Cross-sectional Study
An observational study of Incisional Hernia and Recurrent Hernia, run by Fudan University at 1 site in China.
Trial summary
Purpose Chronic obstructive pulmonary disease (COPD) is a risk factor for incisional hernia, COPD has persistent airflow restriction and pulmonary ventilation dysfunction. The aim of this study was to compare differences in pulmonary ventilation function between primary incisional hernia and recurrent incisional… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Incisional Hernia, Recurrent Hernia, COPD
- What is being tested?
- the incisional hernia recurrent
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 164 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 31 Jul 2023
- 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 diagnosed with "abdominal incisional hernia"and complete data
Who may be able to join
- Abdominal incisional hernia
- Complete CT imagings of the abdomen and pulmonary function tests data
Who cannot join
- Abdominal external hernia, such as parastomal hernias and umbilical hernias
- Primary incisional hernia less than one year when the study started
Trial locations and contacts
1 site in 1 country.
About this study
Purpose Chronic obstructive pulmonary disease (COPD) is a risk factor for incisional hernia, COPD has persistent airflow restriction and pulmonary ventilation dysfunction. The aim of this study was to compare differences in pulmonary ventilation function between primary incisional hernia and recurrent incisional hernia.
Method According to the inclusion and exclusion criteria,Patients diagnosed with "incisional hernia" in our hospital's electronic medical record system were divided into two groups: primary group and recurrent group based on whether the incisional hernia recurred after incisional hernia repair,who were screened out with abdominal wall incisional hernia.The patient information of the two groups were collected, examined and recorded.The clinical data was analyzed by using statistical analysis software.
Read the detailed description
Method Study design and patient population: This study is a single-center cross-sectional study. The main steps of this study are patients search, information review, data record, data verification and statistical analysis.
The investigators searched the electronic medical record system from January 2016 to March 2023, using the 10th edition of the International Classification of Diseases (ICD-10).
Inclusion and exclusion criteria The investigators reviewed the physical examination records of each patient, combined with abdominal CT images, only patients diagnosed with "abdominal incisional hernia" were included in our study, patients with other types of abdominal external hernia, such as parastomal hernias and umbilical hernias, were excluded.
CT imagings of the abdomen and pulmonary function tests were two required items. Patients with incomplete data were excluded, patients with complete data were included in the study and were divided into two groups: primary group and recurrent group depends on whether there is a recurrence.
Because primary incisional hernia may turn into recurrence. To reduce error, patients with primary incisional hernia less than one year when the study was started were excluded, the investigators conducted telephone follow-up of patients with primary incisional hernia. Recurrence after repair was the main outcome, patients with follow-up results of non-recurrence were included in the study. Patients who have recurrent require reassessment of pulmonary function, the patients with missing pulmonary function are excluded.
The search was carried out by two researchers who extracted data independently and the results were double-checked; Diagnosis is done independently by two experienced surgeons, based on medical history and CT images. If there is disagreement, it will be determined after discussion with a third experienced surgeon.
Data Collection The investigators extracted the patient's age, gender, ethnicity, BMI, abdominal CT image, maximum length of abdominal wall defect, hypertension, diabetes, coronary heart disease and pulmonary function test report, pulmonary function test including pulmonary ventilation function and pulmonary diffusion function, pulmonary ventilation function is the main observation index of this study. The fixed threshold method often used in China to grade pulmonary ventilation dysfunction[9], our hospital graded the severity of pulmonary ventilation dysfunction with FEV1 as a percentage of the expected value: Mild: >70%; Moderate: 60%~69%; Moderate to severe: 50%~59%; Severe: 35%~49%; Very severe: <35%. The maximum length of the abdominal wall defect is measured using multi-slice helical CT 3D reconstruction technology, which is performed by a radiologist.
Statistical analysis Continuous variables that conform to a normal distribution are tested using an independent sample t-test; Chi-square test and continuous correction chi-square test are used for categorical variables; The grading variables use Wilcoxon's sum test. When P<0.05, the difference was considered statistically significant, and the statistical analysis software used in this study was SPSS Version 20.
- Being tested
- the incisional hernia recurrent
- Keywords
- Incisional Hernia, Recurrent Hernia, COPD, Pulmonary ventilation function
- Medical subject headings
- Incisional Hernia, Hernia, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the incisional hernia recurrentBehavioural
Recurrence after repair was the main outcome
| Study group | Role | What they receive |
|---|---|---|
| The primary group | Patients diagnosed with "incisional hernia" in our hospital's electronic medical record system were divided into two groups: primary group and recurrent group based on whether the incisional hernia recurred after incisional hernia repair,who were screened out with abdominal wall incisional hernia. | |
| The recurrent group | Patients diagnosed with "incisional hernia" in our hospital's electronic medical record system were divided into two groups: primary group and recurrent group based on whether the incisional hernia recurred after incisional hernia repair,who were screened out with abdominal wall incisional hernia. Receives: Behavioral: the incisional hernia recurrent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent
Recurrence after surgery repair
Measured: 2016.1-2023.3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Mar 2023
- Primary completion1 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional HerniaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhijun Bao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991024
- Sponsor's protocol ID
- HuadongHosptialHernia
- Status last verified
- Aug 2023
- First submitted
- 5 Aug 2023
- Last updated
- 16 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I have to make sure that the patient's privacy and rights are adequately protected
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Ventilation Function Between Patients With Primary and Recurrent Incisional Hernia: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05991024
- Acronym / sponsor ID
- HuadongHosptialHernia
- Keywords
- Incisional Hernia, Recurrent Hernia, COPD, Pulmonary ventilation function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 14 Aug 2023 (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.
Purpose Chronic obstructive pulmonary disease (COPD) is a risk factor for incisional hernia, COPD has persistent airflow restriction and pulmonary ventilation dysfunction. The aim of this study was to compare differences in pulmonary ventilation function between primary incisional hernia and recurrent incisional hernia.
Method According to the inclusion and exclusion criteria,Patients diagnosed with "incisional hernia" in our hospital's electronic medical record system were divided into two groups: primary group and recurrent group based on whether the incisional hernia recurred after incisional hernia repair,who were screened out with abdominal wall incisional hernia.The patient information of the two groups were collected, examined and recorded.The clinical data was analyzed by using statistical analysis software.
Detailed description
Method Study design and patient population: This study is a single-center cross-sectional study. The main steps of this study are patients search, information review, data record, data verification and statistical analysis.
The investigators searched the electronic medical record system from January 2016 to March 2023, using the 10th edition of the International Classification of Diseases (ICD-10).
Inclusion and exclusion criteria The investigators reviewed the physical examination records of each patient, combined with abdominal CT images, only patients diagnosed with "abdominal incisional hernia" were included in our study, patients with other types of abdominal external hernia, such as parastomal hernias and umbilical hernias, were excluded.
CT imagings of the abdomen and pulmonary function tests were two required items. Patients with incomplete data were excluded, patients with complete data were included in the study and were divided into two groups: primary group and recurrent group depends on whether there is a recurrence.
Because primary incisional hernia may turn into recurrence. To reduce error, patients with primary incisional hernia less than one year when the study was started were excluded, the investigators conducted telephone follow-up of patients with primary incisional hernia. Recurrence after repair was the main outcome, patients with follow-up results of non-recurrence were included in the study. Patients who have recurrent require reassessment of pulmonary function, the patients with missing pulmonary function are excluded.
The search was carried out by two researchers who extracted data independently and the results were double-checked; Diagnosis is done independently by two experienced surgeons, based on medical history and CT images. If there is disagreement, it will be determined after discussion with a third experienced surgeon.
Data Collection The investigators extracted the patient's age, gender, ethnicity, BMI, abdominal CT image, maximum length of abdominal wall defect, hypertension, diabetes, coronary heart disease and pulmonary function test report, pulmonary function test including pulmonary ventilation function and pulmonary diffusion function, pulmonary ventilation function is the main observation index of this study. The fixed threshold method often used in China to grade pulmonary ventilation dysfunction[9], our hospital graded the severity of pulmonary ventilation dysfunction with FEV1 as a percentage of the expected value: Mild: >70%; Moderate: 60%~69%; Moderate to severe: 50%~59%; Severe: 35%~49%; Very severe: <35%. The maximum length of the abdominal wall defect is measured using multi-slice helical CT 3D reconstruction technology, which is performed by a radiologist.
Statistical analysis Continuous variables that conform to a normal distribution are tested using an independent sample t-test; Chi-square test and continuous correction chi-square test are used for categorical variables; The grading variables use Wilcoxon's sum test. When P<0.05, the difference was considered statistically significant, and the statistical analysis software used in this study was SPSS Version 20.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The primary group | – | –Patients diagnosed with "incisional hernia" in our hospital's electronic medical record system were divided into two groups: primary group and recurrent group based on whether the incisional hernia recurred after incisional hernia repair,who were screened out with abdominal wall incisional hernia. |
| The recurrent group | – | Behavioral: the incisional hernia recurrentPatients diagnosed with "incisional hernia" in our hospital's electronic medical record system were divided into two groups: primary group and recurrent group based on whether the incisional hernia recurred after incisional hernia repair,who were screened out with abdominal wall incisional hernia. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients diagnosed with "abdominal incisional hernia"and complete data
Key inclusion criteria (2 listed)
- Abdominal incisional hernia
- Complete CT imagings of the abdomen and pulmonary function tests data
Key exclusion criteria (2 listed)
- Abdominal external hernia, such as parastomal hernias and umbilical hernias
- Primary incisional hernia less than one year when the study started
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 |
|---|---|---|
| the incisional hernia recurrentRecurrence after repair was the main outcome | Behavioural | The recurrent group |
Primary outcome
Recurrent
Time frame: 2016.1-2023.3
Recurrence after surgery repair
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 16 Aug 2023.
- Individual participant dataSharing planned: No. I have to make sure that the patient's privacy and rights are adequately protected
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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 Incisional Hernia and Recurrent Hernia, run by Fudan University 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 2 inclusion and 2 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 16 Aug 2023. 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?
Recurrent (time frame: 2016.1-2023.3). 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 16 Aug 2023.