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Does the Use of Prophylactic Mesh Reduce Incisional Hernia?

Primary Purpose

Incisional Hernia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
primary abdominal closure
abdominal closure with prophylactic mesh
Sponsored by
Konya City Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Incisional Hernia focused on measuring incisional hernia, prophylactic, mesh, emergency surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Health Science University Konya City Hospital General Surgery Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

the primary suture group

mesh group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

primary outcome
incisional hernia rate

Secondary Outcome Measures

secondary outcome
seroma rate
secondary outcome
hematoma rate
secondary outcome
burst abdomen rate
secondary outcome
deep vein thymbosis rate
secondary outcome
pulmonary and cardiac complication rate
secondary outcome
mean operation time (minute)
secondary outcome
mean hospital stay time (day)
secondary outcome
chronic pain rate (visual analog scale, VAS)
secondary outcome
quality of life measures (0-100 points) - It will be measured using the EQ-5D test.
secondary outcome
re-operation rate

Full Information

First Posted
December 19, 2020
Last Updated
August 16, 2022
Sponsor
Konya City Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04700956
Brief Title
Does the Use of Prophylactic Mesh Reduce Incisional Hernia?
Official Title
Does Prophylactic Mesh Placement in Emergency Midline Laparotomy Reduce the Incidence of Incisional Hernia? A Prospective Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 19, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konya City Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incisional Hernia
Keywords
incisional hernia, prophylactic, mesh, emergency surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the primary suture group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
mesh group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
primary abdominal closure
Other Intervention Name(s)
primary abdominal closure with suture
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
abdominal closure with prophylactic mesh
Intervention Description
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.
Primary Outcome Measure Information:
Title
primary outcome
Description
incisional hernia rate
Time Frame
up to one year
Secondary Outcome Measure Information:
Title
secondary outcome
Description
seroma rate
Time Frame
up to one months
Title
secondary outcome
Description
hematoma rate
Time Frame
up to one months
Title
secondary outcome
Description
burst abdomen rate
Time Frame
up to ten days
Title
secondary outcome
Description
deep vein thymbosis rate
Time Frame
up to one months
Title
secondary outcome
Description
pulmonary and cardiac complication rate
Time Frame
up to one months
Title
secondary outcome
Description
mean operation time (minute)
Time Frame
up to one hundred twenty minutes
Title
secondary outcome
Description
mean hospital stay time (day)
Time Frame
up to twenty days
Title
secondary outcome
Description
chronic pain rate (visual analog scale, VAS)
Time Frame
up to one year
Title
secondary outcome
Description
quality of life measures (0-100 points) - It will be measured using the EQ-5D test.
Time Frame
up to one year
Title
secondary outcome
Description
re-operation rate
Time Frame
up to one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Health Science University Konya City Hospital General Surgery Department
City
Konya
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32057193
Citation
Jairam AP, Lopez-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. 2020 Jun;4(3):357-368. doi: 10.1002/bjs5.50261. Epub 2020 Feb 14.
Results Reference
result
PubMed Identifier
28400141
Citation
Argudo N, Iskra MP, Pera M, Sancho JJ, Grande L, Lopez-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. 2017 Apr;95(4):222-228. doi: 10.1016/j.ciresp.2017.03.010. Epub 2017 Apr 8. English, Spanish.
Results Reference
result
PubMed Identifier
23712289
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/s10029-013-1119-2. Epub 2013 May 28.
Results Reference
result
PubMed Identifier
26189071
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: 10.1016/j.surg.2015.02.030. Epub 2015 Jul 15.
Results Reference
result
PubMed Identifier
23568247
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.
Results Reference
result
PubMed Identifier
21547421
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.
Results Reference
result
PubMed Identifier
28864937
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.
Results Reference
result
PubMed Identifier
30288617
Citation
San Miguel C, Melero D, Jimenez E, Lopez P, Robin A, Blazquez LA, Lopez-Monclus J, Gonzalez E, Jimenez C, Garcia-Urena MA. Long-term outcomes after prophylactic use of onlay mesh in midline laparotomy. Hernia. 2018 Dec;22(6):1113-1122. doi: 10.1007/s10029-018-1833-x. Epub 2018 Oct 4.
Results Reference
result
PubMed Identifier
25575254
Citation
Garcia-Urena MA, Lopez-Monclus J, Hernando LA, Montes DM, Valle de Lersundi AR, Pavon CC, Ceinos CJ, Quindos PL. Randomized controlled trial of the use of a large-pore polypropylene mesh to prevent incisional hernia in colorectal surgery. Ann Surg. 2015 May;261(5):876-81. doi: 10.1097/SLA.0000000000001116.
Results Reference
result

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Does the Use of Prophylactic Mesh Reduce Incisional Hernia?

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