Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05991024 |
| Other study ID # |
HuadongHosptialHernia |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2023 |
| Est. completion date |
July 31, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
Fudan University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 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.
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.
