Does the Use of Prophylactic Mesh Reduce Incisional Hernia?

Incisional Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04700956
• Other study ID #: 20202020
• Status: Completed
• Phase: N/A
• Start date: December 19, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: Konya City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia

Intervention

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.

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.

Locations

Country	Name	City	State
Turkey	Health Science University Konya City Hospital General Surgery Department	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Konya City Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (9)

Argudo N, Iskra MP, Pera M, Sancho JJ, Grande L, López-Cano M, Pereira JA. The use of an algorithm for prophylactic mesh use in high risk patients reduces the incidence of incisional hernia following laparotomy for colorectal cancer resection. Cir Esp. 20 — View Citation

Bhangu A, Fitzgerald JE, Singh P, Battersby N, Marriott P, Pinkney T. Systematic review and meta-analysis of prophylactic mesh placement for prevention of incisional hernia following midline laparotomy. Hernia. 2013 Aug;17(4):445-55. doi: 10.1007/s10029-0 — View Citation

Fischer JP, Basta MN, Wink JD, Krishnan NM, Kovach SJ. Cost-utility analysis of the use of prophylactic mesh augmentation compared with primary fascial suture repair in patients at high risk for incisional hernia. Surgery. 2015 Sep;158(3):700-11. doi: 10. — View Citation

García-Ureña MÁ, López-Monclús J, Hernando LA, Montes DM, Valle de Lersundi AR, Pavón CC, Ceinos CJ, Quindós PL. Randomized controlled trial of the use of a large-pore polypropylene mesh to prevent incisional hernia in colorectal surgery. Ann Surg. 2015 M — View Citation

Jairam AP, López-Cano M, Garcia-Alamino JM, Pereira JA, Timmermans L, Jeekel J, Lange J, Muysoms F. Prevention of incisional hernia after midline laparotomy with prophylactic mesh reinforcement: a meta-analysis and trial sequential analysis. BJS Open. 202 — View Citation

Kurmann A, Barnetta C, Candinas D, Beldi G. Implantation of prophylactic nonabsorbable intraperitoneal mesh in patients with peritonitis is safe and feasible. World J Surg. 2013 Jul;37(7):1656-60. doi: 10.1007/s00268-013-2019-4. — View Citation

Llaguna OH, Avgerinos DV, Nagda P, Elfant D, Leitman IM, Goodman E. Does prophylactic biologic mesh placement protect against the development of incisional hernia in high-risk patients? World J Surg. 2011 Jul;35(7):1651-5. doi: 10.1007/s00268-011-1131-6. — View Citation

Payne R, Aldwinckle J, Ward S. Meta-analysis of randomised trials comparing the use of prophylactic mesh to standard midline closure in the reduction of incisional herniae. Hernia. 2017 Dec;21(6):843-853. doi: 10.1007/s10029-017-1653-4. Epub 2017 Sep 1. R — View Citation

San Miguel C, Melero D, Jiménez E, López P, Robin Á, Blázquez LA, López-Monclús J, González E, Jiménez C, García-Ureña MÁ. Long-term outcomes after prophylactic use of onlay mesh in midline laparotomy. Hernia. 2018 Dec;22(6):1113-1122. doi: 10.1007/s10029 — View Citation

Outcome

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