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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

China1 site
  • Yiming Lin

    Shanghai, 000000

Other trials in China

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 groups in NCT05991024
Study groupRoleWhat they receive
The primary groupPatients 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 groupPatients 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.

  1. 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.

  1. First posted14 Aug 2023
  2. Study start1 Mar 2023
  3. Primary completion1 Jul 2023
  4. Study completion31 Jul 2023

Resources

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)
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

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.

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