Does the Use of Prophylactic Mesh Reduce Incisional Hernia?

Study Overview
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Brief Summary
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Incisional hernia is a common condition after abdominal surgery. Because linea alba has less vascularity, incisional hernia more common in midline incisions. It is seen in the general population between 11-20%. In some high-risk situations, this rate increases up to 40-69% (abdominal aortic aneurysm, morbid obesity, colorectal surgery).It is known that incisional hernia that occurs in the postoperative period can lead to emergency surgical causes such as incarceration-strangulation, has a significant share in health expenses and seriously impairs the quality of life in patients.One of the methods tried to reduce incisional hernia is the use of mesh. But this abdominal closure technique is not used routinely in our country and the other countries. This study will be important of the studies in Turkey and world for patient selection in prophylactic mesh use, techniques to be applied and early / late results. The aim of the study is to compare the classical abdominal closure technique with use of mesh in order to minimize the incisional hernia and associated complications after midline laparotomy.

Detailed Description
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Background There are patient and surgical procedure-related risk factors that increase the risk of postoperative incisional hernia. Patient-related risk factors: male gender, previous laparotomy, over 50 years of age, malignant disease, COPD, hypoalbuminemia, sepsis, obesity (BMI> 30 kg / m2), anemia, DM, used to steroid, smoking, chemoterapi, cardiovascular disease, RT to the abdominal wall and to be postoperative abdominal wall defects. In studies conducted in many centers around the world, it has been shown that the use of prophylactic mesh reduces the incidence of incisional hernia, especially in high-risk patients. When the literature was reviewed, reviews and meta-analyzes about the use of prophylactic mesh showed a significant decrease in incisional hernia incidence. However, routine practice has not yet been recommended, as long-term follow-up results and secondary results (complications, cost analysis, quality of life) are not clearly explained. However, it has been reported that higher quality studies are needed. This abdominal closure technique is not used routinely in our country. This study will be one of the first studies in Turkey for patient selection in prophylactic mesh use, techniques to be applied and early / late results. The aim of the study is to compare the classical abdominal closure technique with use of mesh in order to minimize the incisional hernia and associated complications after midline laparotomy. Method Patients aged 18 years and over who were scheduled to undergo emergency abdominal surgery with midline laparotomy will be randomly assigned (1: 1) to primary abdominal closure or mesh group via a computer-generated randomization sequence. Detailed information was given to all patients before they were included in the study, and their informed consent forms were recorded. The method in the primary suture group: The linea alba will be closed to a ratio of 5mm / 5mm. Only the fascia will be sutured ; fat or muscle tissue will be avoided. Subcutaneous tissue will be closed with polyglactin 3/0 suture. The skin will be closed with a stapler. Method in the mesh group: After the fascia was closed with the same method, 5 cm of subcutaneous tissue will be dissected around the incision. The mesh will be placed in the supra-aponeurotic area (onlay) to a distance of laterally and cranial-caudally 5 cm from the fascia margins. The mesh used will be partially absorbable, light and large porous. After this procedure, the borders of the mesh will be fixed circumferentially on the abdominal wall using polypropylene suture to prevent the intestines from herniating on the mesh. Two subcutaneous drainage catheters will be placed in all patients with mesh. Antithrombotic prophylaxis with low molecular weight heparin, antibiotic prophylaxis with cefazolin and metronidazole will be applied to all patients according to the hospital protocol. Power analysis; To provide sufficient statistical power, sample size calculation was made. Incisional hernia rates were estimated between 5% and 25% between the two groups. It was calculated that 49 patients per group with 80% test power in the 95% confidence interval would be needed. In the follow-up period, it was planned to include 52 patients in each group, with the prediction that 5% of the patients would be excluded from the study. Data Entry and Statistical Analysis; Kolmogorov-Smirnov and Shapiro-Wilk normality tests will be carried out before starting the statistical analysis. If normality cannot be achieved even in one of the groups, non-parametric test methods will be selected. Next, the Mann-Whitney U test will be used to compare the variables obtained by the measurement between the two groups. Chi-square and Fisher Final tests will be used to analyze the relationships or differences between groups in terms of categorical variables. Univariate logistic regression analysis will be performed to determine the factors thought to cause an incisional hernia. Then, multivariate logistic regression analysis will be done for variables with

Official Title
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Does Prophylactic Mesh Placement in Emergency Midline Laparotomy Reduce the Incidence of Incisional Hernia? A Prospective Randomized Clinical Trial

Conditions
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Incisional Hernia

Intervention / Treatment
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* Procedure: primary abdominal closure
* Device: abdominal closure with prophylactic mesh


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being older than 18 years of age, laparotomy with the midline incision of the abdomen, all emergency surgery indications, having at least two of the risk factors. Exclusion Criteria: Patients under 18 years of age, elective surgeries, off-midline incisions, concurrent hernia, laparoscopic surgery, history of metastatic cancer, life expectancy less than 2 years, pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: the primary suture group<br>The linea alba will be closed to a ratio of 5mm / 5mm. Only the fascia will be sutured ; fat or muscle tissue will be avoided. Subcutaneous tissue will be closed with polyglactin 3/0 suture. The skin will be closed with a stapler. | Procedure: primary abdominal closure<br>* The linea alba will be closed to a ratio of 5mm / 5mm. Only the fascia will be sutured ; fat or muscle tissue will be avoided. Subcutaneous tissue will be closed with polyglactin 3/0 suture. The skin will be closed with a stapler.<br>* Other names: primary abdominal closure with suture;|
| Experimental: mesh group<br>After the fascia was closed with the same method, 5 cm of subcutaneous tissue will be dissected around the incision. The mesh will be placed in the supra-aponeurotic area (onlay) to a distance of laterally and cranial-caudally 5 cm from the fascia margins. The mesh used will be partially absorbable, light and large porous. After this procedure, the borders of the mesh will be fixed circumferentially on the abdominal wall using polypropylene suture to prevent the intestines from herniating on the mesh. Two subcutaneous drainage catheters will be placed in all patients with mesh. | Device: abdominal closure with prophylactic mesh<br>* After the fascia was closed with the same method, 5 cm of subcutaneous tissue will be dissected around the incision. The mesh will be placed in the supra-aponeurotic area (onlay) to a distance of laterally and cranial-caudally 5 cm from the fascia margins. The mesh used will be partially absorbable, light and large porous. After this procedure, the borders of the mesh will be fixed circumferentially on the abdominal wall using polypropylene suture to prevent the intestines from herniating on the mesh. Two subcutaneous drainage catheters will be placed in all patients with mesh.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| primary outcome | incisional hernia rate | up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| secondary outcome | seroma rate | up to one months | 
| secondary outcome | hematoma rate | up to one months | 
| secondary outcome | burst abdomen rate | up to ten days | 
| secondary outcome | deep vein thymbosis rate | up to one months | 
| secondary outcome | pulmonary and cardiac complication rate | up to one months | 
| secondary outcome | mean operation time (minute) | up to one hundred twenty minutes | 
| secondary outcome | mean hospital stay time (day) | up to twenty days | 
| secondary outcome | chronic pain rate (visual analog scale, VAS) | up to one year | 
| secondary outcome | quality of life measures (0-100 points) - It will be measured using the EQ-5D test. | up to one year | 
| secondary outcome | re-operation rate | up to one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prophylactic, mesh, emergency surgery, incisional hernia