Does the Use of Prophylactic Mesh Reduce Incisional Hernia?

August 16, 2022 updated by: Mehmet Eşref Ulutaş, Konya City Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

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

  • Turkey
      • Konya, Turkey
        • Health Science University Konya City Hospital General Surgery Department

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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
Procedure: primary abdominal closure
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.
Other Names:
  • primary abdominal closure with suture
EXPERIMENTAL: 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.
Device: abdominal closure with prophylactic mesh
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Konya City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 19, 2020

Primary Completion (ACTUAL)

June 30, 2022

Study Completion (ACTUAL)

June 30, 2022

Study Registration Dates

First Submitted

December 19, 2020

First Submitted That Met QC Criteria

January 7, 2021

First Posted (ACTUAL)

January 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 17, 2022

Last Update Submitted That Met QC Criteria

August 16, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20202020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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