Prophylactic Mesh Placement Reduces the Incidence of Incisional Hernia in HBP Surgery.
Phase: NA
Conditions: Hernia Incisional, Incision Site Complication
Sponsor: Juan Bellido-Luque.MD

 
 
 
 
 
 
 
 
 
 
 
 
 
 
TITLE 
Prophylactic Mesh Placement Reduces the 
Incidence of Incisional Hernia in HBP 
Surgery. 
 
 
 
 
 
 

 
CICAT STUDY  
PREVENTION OF INCISIONAL HERNIA WITH PROPHYLACTIC MESH VERSUS PRIMARY SUTURE 
AFTER RIGHT SUBCOSTAL LAPAROTOMY. A DOUBLE-BLIND, RANDOMIZED, MULTICENTER 
CONTROLLED STUDY.  
GENERAL INFORMATION 
PROMOTER 
Juan Antonio Bellido Luque 
General and Digestive System Surgery Service of the Virgen Macarena Hospital, Seville  
 
PARTICIPATING CENTERS  
1. 
Virgen Macarena University Hospital, Seville.   
STUDY RESEARCHERS 
1. 
Principal Investigator: Juan Antonio Bellido Luque 
2. 
Researchers responsible for the Virgen Macarena Hospital: Inmaculada Sanchez-
Matamoros and Angel Nogales Muñoz.   
EXPECTED DURATION 
24 months 
INTRODUCTION 
In middle laparotomies, and despite the principles of correct closure of the abdominal wall (4:1 
rule, small stitches and monofilament suture in a single aponeurotic plane) the incidence of 
incisional hernia occurs around 12.8% during the first two years. In patients with risk factors and 
with longer follow-up, the incidence rate increases. (1) 
To avoid the appearance of incisional hernia, especially in patients at risk, the use of prophylactic 
meshes has been used in the closure of the middle laparotomies. One of the initial resistances 
to the widespread use of this procedure is the fear of infection and the possible complications 
derived from the use of them. 
In an overall analysis of 1759 patients in whom a prophylactic mesh has been used in mean 
laparotomies, the overall wound infection rate was 12% and the mesh infection rate was 0.6%. 
The evidence analyzed indicates that the procedure may be safe in clean and clean 
contaminated surgery. There is no evidence regarding the use of them in dirty or contaminated 
surgery. (2) 
In most published studies, the meshes used are permanent synthetic meshes and in some cases 
absorbable biological or synthetic mesh. 

Regarding the position of the mesh, supraaponeurotic placement seems to be as safe as 
retromuscular placement, in terms of prophylaxis of incisional hernia in medium laparotomies.  
Although the results regarding the decrease in the incidence of incisional hernia seem to justify 
the use of prophylactic meshes in the closure of mean laparotomies, more studies are needed 
to identify the risk factors of patients in which to do so with a high level of evidence. (3) 
Subcostal incisions continue to be one of the most widely used ways of approaching the 
abdominal cavity, especially in the esophagogastric and hepatobiliopancreatic units, and despite 
the implementation of minimally invasive surgery. 
The incidence of IH (Incisional Hernia) in subcostal laparotomies reported in the literature is 
estimated to be around 4.8%-31.3% according to the different published series. Although this 
incidence is lower than that reported in the case of medium laparotomies, their treatment is 
more complex for two reasons: 
1. 
The rectus muscle is divided into two parts, whose ends are separated to a greater or 
lesser extent depending on the size of the hernia defect, making it difficult to repair 
completely and reposition it in its original position. 
2. 
Because of their proximity to the rib bone ridge. (4) 
The repair of subcostal IH has a recurrence rate of 25% and they are included in the group of the 
so-called complex eventrations, due to the characteristics described above. (3) 
Currently, following the recommendations of the EHS regarding the prophylactic use of meshes 
in the closure of mean laparotomies, it seems that it can be an effective procedure to reduce 
the incidence of IH, especially in patients at high risk of developing it, although a greater number 
of studies are needed. 
In relation to subcostal laparotomies, there is no indication with a level of evidence in this 
guideline. (3) 
Only in a study published in Surgery 2016, in bilateral subcostal incisions, does the use of 
prophylactic mesh appear to be safe and effective and reduces the incidence of IH in such 
laparotomies. (6) 
Faced with this problem, the scarcity of literature on the subject, and following the trend of 
eventration prophylaxis with the use of midline meshes, the hypothesis of this working group in 
right unilateral subcostal laparotomies arises. 
HYPOTHESIS 
The use of a prophylactic mesh in a subaponeurotic position in the closure of a right unilateral 
subcostal laparotomy reduces the incidence of incisional hernia without increasing the incidence 
of complications. 

OBJECTIVES 
MAIN OBJECTIVE 
To study the incidence of incisional hernia during the first two postoperative years in patients 
operated on with a right unilateral subcostal laparotomy, in both groups, with and without 
prophylactic mesh. 
SECONDARY OBJECTIVES 
 
1. 
Evaluation of surgical wound complications 
1. 
To evaluate and compare the incidence of superficial and deep surgical site 
infection in patients who underwent surgery. 
2. 
To evaluate and compare the incidence of Seromas in operated patients. 
3. 
To assess and compare the incidence of bruising in patients undergoing surgery 
4. 
To evaluate the incidence of evisceration in operated patients. 
2. 
Study scar pain one month and three months after surgery. 
SOURCE OF INFORMATION  
The information will be obtained in all cases from the medical records of patients who have 
given their consent for the use of their data, and from interviews between them and the 
researchers. In no case will any procedure be performed outside of routine clinical practice, in 
order to obtain any data requested within the scope of this study.  
STUDY DESIGN 
Prospective, multicenter, randomized study. The assignment will be randomized into two 
groups: 
1. 
Group 1: Prophylactic mesh. (Dynamesh Cicat®). 
2. 
Group 2: Primary closure 
SAMPLE SIZE 
100 patients (100 each Group) 
 
RANDOMIZATION AND MASKING 
1. 
The assignment of each patient to each of the two study groups will be carried out by 
randomization generated by computer program.  
2. 
The follow-up and assessment of complications will be carried out by an investigator 
other than the surgeon performing the intervention. 
 
 

STUDY POPULATION 
 
INCLUSION CRITERIA 
 
1. 
 Patients over 18 years of age. 
2. 
 Patients who are going to be operated on by means of a unilateral right or right extended 
subcostal laparotomy.  
3. 
 Patients who have given written informed consent. 
4. 
 Patients with 2 or more risk factors for incisional hernia:  
• Age > 60 years  
• BMI (body mass index)  > 27 
• Diabetes  
• Chronic bronchopathy 
• Heart disease 
• Smoker  
• Neoplasia  
• Kidney failure  
• Liver disease  
• Immunosuppression  
 
EXCLUSION CRITERIA 
 
1. 
 Emergency surgery. 
2. 
 Laparotomies in liver transplantation. 
3. 
 Prior eventration. 
4. 
 Previous laparotomy with a localized scar on the area to be made.  
5. 
  Presence of peritoneal carcinomatosis or advanced tumors with an estimated survival of 
less than 12 months. 
6. 
 Hemodynamic instability during surgery 
7. 
 Concurrent participation in another study that interferes with the intervention and/or 
outcomes. 
8. 
 Iron allergy. 
9. 
  Withdrawal or lack of written consent. 
10. 
 Patients with sufficient cognitive impairment to prevent understanding of the patient 
information sheet and informed consent. 
 
WITHDRAWAL CRITERIA 

1. 
The subject will be considered included in the study when, meeting the selection criteria, 
they give consent and the data corresponding to the baseline visit are recorded in a 
database. The participant may revoke his/her consent to participate in the study or to 
the use of his/her data in the analysis at any time, without justifying his/her decision, 
and without any liability or damage being derived for him/her. 
2. 
Any patient who has to be reoperated within the first 30 postoperative days with removal 
of the implanted mesh and does not have a new mesh reimplanted.  
 
OBSERVATION PERIOD 
In addition to the assessment of postoperative complications during admission, the patient will 
be monitored at one month, 3 months, 6 months, 12 months, 18 months and 24 months after 
surgery in scheduled visits in the outpatient clinics of the respective services participantes.  
METHODS OF CLOSING THE ABDOMINAL WALL  
1. 
Before closing the abdominal wall, gloves will be changed and sterile material will be 
used for this purpose. 
2. 
The closure of the abdominal wall will be performed with continuous suture of long-
lasting synthetic monofilament nº 0 with a ratio of 4:1 in 2 planes and with the stitches 
separated at distances between 0.5 and 1 cm and taking 5 mm of tissue on each side.  
3. 
The first layer will include the internal oblique muscle, transverse muscle and the 
posterior sheath of the rectum. The second layer will include the external oblique 
muscle, its aponeurosis, and the anterior sheath of the rectum.  
4. 
In the case of random assignment to the "mesh" group, a medium/low-density, wide-
pore polyvinylidene fluoride (PVDF) mesh (Dynamesh Cicat®) will be implanted in a 
retromuscular position, fixing the edges with intersecting dots of 2/0 resorbable 
monofilament 3/0 separated from each other by 3 cm. The mesh will be trimmed in 
length to fit the dissected space and the length of the incision, so that it exceeds the 
lateral and longitudinal edges of the incision by 3 cm.  
5. 
The subcutaneous cellular tissue will be approached with 2/0 polyglycolic acid points, 
taking mesh to reduce dead spaces. The skin will approach with staples  
 
 
 
FOLLOW-UP 
Postoperative hospital stay. 
Any readmission in the first two years after the procedure.  
Follow-up in consultations at one month and then at 3, 6, 12, 18 and 24 months. 
VARIABLES TO BE ANALYZED 
1. 
Preoperative variables: 
1. 
Age.  
2. 
Sex.  
3. 
BMI 

4. 
Diabetes mellitus.  
5. 
Chronic treatment with corticosteroids.  
6. 
Malnutrition (plasma albumin < 3.5 mg/dl).  
7. 
COPD (Chronic obstructed pulmonary disease)  
8. 
Smoking.  
9. 
Connective tissue diseases (presence of aortic aneurysm). 
10. 
Liver disease 
11. 
Immunosuppression 
12. 
Coagulopathy 
13. 
Neoplasia 
14. 
Diagnosis 
 
2. 
Intraoperative variables: 
1. 
Day of the intervention 
2. 
Surgeon 
3. 
Surgical intervention performed.  
4. 
Incision length 
5. 
Mesh Size Placed: Length x Width 
6. 
Type of surgery (clean, clean-contaminated, contaminated, dirty). 
7. 
Benign vs malignant pathology 
8. 
Operating time (minutes). 
9. 
Intraoperative complications.               
10. 
Perioperative blood transfusion.  
 
 
3. 
Postoperative variables: 
1. 
Local complications: 
1. 
Surgical wound infection: superficial, deep or organ-space (based on Magram 
guidelines).  
2. 
Seroma 
3. 
Evisceration 
4. 
Hematoma 
2. 
Systemic complications: 
1. 
Respiratory complications 
2. 
Cardiac 
3. 
Renal 
4. 
Septic shock 
5. 
ITU ( urinary infection) 
6. 
Catheter 
7. 
Paralytic ileus 
8. 
Fistula/dehiscence 
9. 
Reoperation  
3. 
Postoperative stay. 
4. 
VAS (Visual analogical scale) at discharge, at one month and at 3 months. 
5. 
Re-entry rate. 
6. 
Mortality.  

1. 
Incidence of eventration after surgery (clinical or radiological diagnosis) and time of 
onset (3, 6, 12, 16 or 18 months). CT ( computed scan) of the abdomen at 12 months, 
abdominal wall assessment 
2. 
MRI (magnetic resonance) abdomen at 6 months to see length and width of the mesh 
placed. And assessment of abdominal wall 
3. 
If there is loss of follow-up, the cause will be collected. 
4. 
Revisions:  
1. 
Eventration. 
2. 
Seroma. 
3. 
Chronic mesh infection. 
 
STATISTICAL ANALYSIS 
An intention-to-treat test will be performed. There will be an analysis of the mean and 
standard deviation for variables with continuous measures, while we will report frequencies 
and percentages for categorical variables. For the comparison of categorical variables, the Chi-
square test or the Fisher test will be used when necessary. For the comparison of continuous 
variables, the Student's "t" test will be used. To identify variables related to the different 
objectives, Cox's linear, logistic or proportional multivariate analyses will be used. The 
occurrence of IH during follow-up will be analyzed using the Kaplan-Meier method. All analyses 
will be performed with hypothesis testing of 2 tails and a significance level of 5%. Statistical 
calculations will be performed with SPSS (SPSS Inc., Chicago, Illinois).  
 
SAFETY 
The safety of using a prophylactic mesh in the closure of laparotomies has been extensively 
demonstrated in different cohort studies and published clinical trials. 
The mesh is approved for the use of parietal reinforcement and for the prevention of incisional 
hernia. 
 
All adverse events that, in the opinion of the investigator, are relevant and/or related to 
randomized treatments will be collected. 
An adverse event is any undesirable sign, symptom, or clinical condition that occurs after the 
start of the study (or therapy), even if it is considered unrelated to the study treatment. A serious 
adverse event is defined as an adverse event that results in death, threatens life, produces 
permanent disability or results in hospitalization or prolongation of hospitalization; in addition, 
congenital anomalies and malignant processes are also included. 
Serious adverse events that are related or possibly related to the treatments will be reported to 
the Spanish Medicines Agency, to the competent bodies of the Autonomous Community of 
Madrid. 
ETHICAL ASPECTS 
This study should be conducted in accordance with the protocol and the standards of Good 
Clinical Practice (GCP), as described in Directive 91/507/EECC and the Declaration of Helsinki 
concerning medical research involving human subjects ("Recommendations for physicians 
involved in biomedical research involving human subjects"). 
Los investigadores acceden a seguir las instrucciones y procedimientos descritos en el mismo y 
por lo tanto cumplirá los principios de Buena Práctica Clínica en los cuales se basa. 
 

Informed consent 
The investigator must explain to each patient (or legally authorized representative) the nature 
of the study, its purposes, procedures, expected duration, and the potential risks and benefits 
related to participation in the study, as well as any inconveniences that the study may entail. 
Each participant should be advised that their participation in the study is voluntary and that they 
may leave the study at any time, without affecting their subsequent medical treatment or their 
relationship with the treating physician. Informed consent will be provided in the form of a 
standard written document, in language that is easily understandable to the participant. The 
patient must write his/her name and that of the informing physician in his/her own handwriting 
and date and sign the informed consent, as well as receive a copy of the signed document. 
If the subject is unable to read or sign the documents, an oral presentation may be made or the 
signature of the subject's authorized legal representative may be obtained, provided that it is 
witnessed by a witness not involved in the study and is mentioned in the same document and/or 
medical history. 
No patient may be included in the study without prior informed consent. 
CONFIDENTIALITY  
A temporary database will be created that will be hosted both on the website of the European 
Registry of Abdominal Wall Hernias (www.eurahs.eu) and in a database through the cardiolink 
website (www.cardiolink.es). Patients will be identified by an order number and by the medical 
record number. Only study researchers will have access to this database. In any case, these data 
will be handled in accordance with the Organic Law on the Protection of Personal Data 15/1999, 
of 13 December.