Pulmonary Ventilation Function Between Patients With Primary and Recurrent Incisional Hernia: a Cross-sectional Study

August 14, 2023 updated by: Zhijun Bao, Fudan University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
164

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 000000
        • YiMing Lin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

patients diagnosed with "abdominal incisional hernia"and complete data

Description

Inclusion Criteria:

  • Abdominal incisional hernia
  • Complete CT imagings of the abdomen and pulmonary function tests data

Exclusion Criteria:

  • Abdominal external hernia, such as parastomal hernias and umbilical hernias
  • Primary incisional hernia less than one year when the study started

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: the incisional hernia recurrent
Recurrence after repair was the main outcome

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recurrent
Time Frame: 2016.1-2023.3
Recurrence after surgery repair
2016.1-2023.3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 5, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HuadongHosptialHernia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

I have to make sure that the patient's privacy and rights are adequately protected

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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