|Year : 2012 | Volume
| Issue : 3 | Page : 118-123
Laparoscopic incisional hernia repair: Polyester versus Polytetraflouroethylene mesh
Adil Bangash, Mohammad Khan Wazir
Peshawar Institute of Medical Sciences, Peshawar, Pakistan
|Date of Web Publication||11-Jan-2013|
Peshawar Institute of Medical Sciences, Peshawar
Source of Support: None, Conflict of Interest: None
Aims and Objectives: To compare the frequency of complications of laparoscopic repair of incisional hernia between polyester and Polytetraflouroethylene meshes. Materials and Methods: This study was conducted as part of an Interventional multicentre trial at the Rehman Medical Institute Peshawar, Peshawar Institute of Medical Sciences and Pakistan Institute of Medical Science Islamabad from the 1 st of October, 2008 till 30 th September, 2011. The frequency of complications was calculated as the measure of comparing two commercially available meshes for the laparoscopic repair of incisional hernia using the Intrperitoneal placement of mesh (IPOM) technique. These patients were admitted via the out-patient department and their demographic data was collected on a proforma. The size of the defect was evaluated clinically or radiologically and if >10cm were excluded from the study. Forty five patients were alternately placed in either group and group I comprised patients with a ventral hernia that was repaired with composite polyester mesh (Parietex R ) whereas the other group was also repaired laparoscopically but repaired with a Polytetraflouroethylene (Dual R ) mesh. All data was collected on the individual proforma of each patient and was loaded on the SPSS R version 13.0. Results: The BMI (body mass index) in both groups was similar ( P = 1.41). The mean hospital stay was higher in the Polytetraflouroethylene (PTFE) mesh group but the values were not significant ( P = 1.12). No peri-operative death was observed in either group. Five patients (11.11%) from group I were re-admitted with varying complaints and were diagnosed as having sub-acute intestinal obstruction ( P = 0.04). A higher but insignificant recurrence rate was observed in the polyester group over a one year period of follow up. Four patients (8.8%) that were diagnosed with recurrences in group I. Instead the PTFE group had a lower recurrence ( P = 0.91). Conclusion: The frequency of recurrence was similar in both groups. A higher frequency of intestinal obstruction was observed in the polyester group.
Keywords: Incisional hernia, intraperitoneal onlay mesh, laparoscopic repair
|How to cite this article:|
Bangash A, Wazir MK. Laparoscopic incisional hernia repair: Polyester versus Polytetraflouroethylene mesh. J Sci Soc 2012;39:118-23
| Introduction|| |
Ventral hernias comprise only 5% of the workload on a surgeon's daily activity.  Yet being infrequent, it envisages a modest degree of difficulty regarding its management. ,
Strictly speaking ventral hernia includes incisional hernias arising in midline wounds, following laparotomy.  Final result culminating in such a catastrophe from what may have been a simple exploration is related to a number of factors such as technical difficulties and patient (local + systemic) factors. Although the term being limited to non-recurrent incisional hernias as a separate disease entity, the management principles of other hernias arising from the ventral abdominal wall remains similar. ,
Over the last two decades a great degree of work focusing on the technique and various materials involved have dynamically changed the management from a more minimal invasive procedure from the more simple repairs (herniorraphy).  Laparoscopic repair of incisional hernia is a demanding procedure with all benefits in favor but a lower cosmetic result as an isolated procedure. 
Laparoscopic Intrperitoneal placement of mesh (IPOM) has revolutionized the outcome of incisional hernia repair since 1993.  The need for the component replacement technique revolutionized by Ramirez et al.  has been subdued for recurrent or grossly difficult hernias. Incisional hernia repair with conventional techniques such as simple closure or Mayo's repair is associated with high recurrence rates (30-50%).  Lower recurrence rates have been associated with more sophisticated Ramirez component technique and the more common hernioplasty; the back bone of the latter procedure being an inferior cosmetic out come when performed laparoscopically and expense of the procedure. ,,,,,
A wide list of manufacturers claiming the safety of their mesh in terms of reduction in recurrences and lower morbidity; have been described. ,,[ 19] The recommended U.S. Food and Drug Administration (FDA) approved for IPOM materials are mainly, poly vinyl chloride, PTFE and polyester.  These too have their drawbacks thus the introduction of a double component has improved the outcome. One component ensures stable reinforcement to the anterior abdominal wall where as the other (visceral) is to keep the adhesions between the mesh and the bowel to a minimum. ,,[ 23] A fine example in two commonly used meshes is the incorporation of a biological layer such as collagen or its related molecules. The routine use of polypropylene and its lighter weight congener has shown an increased frequency of fistulation. ,,[ 26] Thus far these composite meshes are standing the test of time and although long term studies are yet to be validated; regarding the degree of morbidity and recurrence is to be evaluated.
| Materials and Methods|| |
This study was conducted as part of an Interventional multicentre trial at the Rehman Medical Institute Peshawar, Peshawar Institute of Medical Sciences and Pakistan Institute of Medical Science Islamabad from the 1 st of October, 2008 till 30 th September, 2011. The frequency of complications was calculated as the measure of a modest outcome comparing two commercially available meshes for the laparoscopic repair of incisional hernia using the IPOM technique. By a study conducted by Colon et al.,  the complication rate was highest as 3% in one arm but this was not significant. Using the on web sample size calculator, for 95% confidence interval limit and a 5% margin of error 45 patients were to be placed in each arm assuming a general population. The size accounted to 90 patients.
After this through discussion on the methods and the aims of the study were discussed and documentarily presented to the ethical committee in Lady Reading Hospital Peshawar. After rigorous discussions the hospital fundraising authorities were approached explaining the cost of the procedure the benefits observed from values dictated by other studies were submitted. By this the cost of the mesh was afforded by the hospitals concerned.
The study included all those patients that had a midline laparotomy Aged between 18-55 years, when the indication for the first surgery was non-neoplastic. At the same time rigorous evaluation was done to rule out and exclude those patients with Anemia, Raised BMI, Jaundice, Ascites, ongoing infection or sepsis. Those with large defects and recurrent incisional hernias by the laparoscopic route were also excluded from the study.
The patient was blinded from the type of mesh that was to be incorporated but the type of procedure and the inclusion in a multicentre trial was explained before the consent was obtained. The surgeon was also not informed of the patient's inclusion in the study but the type of mesh applied was inevitable to be observed by the operating surgeon.
These patients were admitted via the out-patient department and their demographic data was collected on a proforma. This included the reason for the first surgery and BMI as well as any other relevant surgery and fertility issues in females. The size of the defect was evaluated clinically or radiologically and if >10cm were excluded from the study.
Pre-operatively a complete history and examination was performed. A set of routine investigations such as a Full Blood Picture, Urea, Serum Creatinine, Electrolytes, Chest X-ray and if needed a Pulmonary function test with a an ECG was performed. These investigations and other supplemented were subjected by the attending anesthetist and surgeon. The patients were alternately placed in either arm. Arm 1 included those patients that were receiving Polyester composite mesh where as the other Arm 2 was receiving a Dual PTFE mesh. All the techniques used were laparoscopic; there forth any conversions were excluded from the study. A 5cm adequate overlap was attained and the appropriately sized mesh was ordered for. All surgeons used sutures to fix the four corners of the mesh to the abdominal wall. Tacks were then placed in between sutures in an inner and outer row. Although most surgeons applied transabdominal sutures, the choice was strictly on the surgeon. In our unit fixation was in comparison with application of fibrin glue as part of another trial.
Majority of the patients were discharged on resumption or oral feeds and passage of flatus. No drains were placed except in cases of overzealous dissection (intra-abdominal).
Patient follow-up was achieved by office records and phone interview to determine hernia recurrence or other operative complications including wound complications, bowel obstruction, or fistula development. Plan of follow-up visit was three weeks, two months, six months and one year.
All data was collected on the individual proforma of each patient and was loaded on the SPSS R version 13.0. All demographic data regarding patients was compared between groups and other preoperative data pertaining to the management was documented on tabulated form. These included size of the defect and associated co-morbidities.
The rest were tested for significance by the Chi-square test. A value of <0.05 was considered significant and to rule out any confounding variables such as sex and age Multi-variate analysis was performed.
| Results|| |
Ninety patients with ventral hernia that had a previous midline laparotomy with no existing co-morbidities were included in the study. 52 patients were male and 38 patients were females. Group I (polyester) group underwent a laparoscopic intraperitoneal onlay mesh placement (IPOM) and were followed similar to patients for group 2, for a period of one year. Apart from the demographic variables and post operative hospital stay mentioned in [Table 1], there was no major difference in the history or social and co-morbid factors between both groups.
Forty five patients were alternately placed in either group and group I comprised patients with a ventral hernia that was repaired with a composite polyester mesh (Parietex R ) where as the other group was also repaired laparoscopically but repaired with a Polytetraflouroethylene (Dual R ) mesh. The BMI in both groups was similar (P = 1.41).
Apart from other demographic figures that held no significant differences, large size defects (>10 cm) (confirmed clinically or by sonography) were excluded from the study. This was to avoid the technical difficulty associated with the procedure, confounding the result by application of an oversized mesh with still inadequate overlap.
The resultant recurrence has been documented by earlier trials of both open and laparoscopic repairs. Yet keeping the limitation in mind the defect size was measured in both groups that was larger (mean) in the polyester group (P = 2.05). Even by multivariate analysis between groups for the age and sex differences the result was not significant. The reason for measuring this value was also the fact that a fair number of surgeons were tending to use the PTFE mesh for larger defects [Table 1].
The dual PTFE mesh was much more difficult to fixation judged by a questionnaire presented to all operating and assisting surgeons. This was again due to lack of access to the recommended fixation suture by company and the fact that the study was part of another trial comparing the method of fixation of the composite polyester mesh. The results were evidently in favor of the composite polyester mesh as the operating time was lesser (164 + 34.7). Relevant data confounding the operative time was the time to completion of adhesiolysis, that varied in individual cases which was similar in both groups (P = 1.00).
The mean hospital stay was higher in the PTFE mesh group but the values were not significant (P = 1.12).
No peri-operative death was observed in either group. Five patients (11.11%) from group I was re-admitted with varying complaints and was diagnosed as having sub-acute intestinal obstruction. X-rays and ultrasonic evidence to support were not required as all of them settled but the mean re-admission hospital stay was 5.2 days (+1.6). In comparison only one patient from the PTFE group was readmitted with intestinal obstruction (P = 0.04) that was significant only not impacting the outcome because none required adhesiolysis [Table 2].
Seroma formation occurred in a few patients from either group but the inference could not be use to draw conclusions as some patients had cosmetic surgery for the overlying scar in the same setting (P = 0.77). Wound infection was only observed in two patients (4.4%), both belonging to the polyester group. One of the patients required removal of mesh but was referred to another centre encompassing a formidable task.
All patients with Seroma formation settled with percutaneous aspiration and aspirate was sent for the culture and sensitivity. A very high number of patients in the polyester group showed persistent pain one month after surgery that settled in most patients, this was observed in only eleven patients that had a PTFE mesh placed (P = 0.573).
A higher but insignificant recurrence rate was observed in the polyester group over a one year period of follow up. Four patients (8.8%) that were diagnosed with recurrences in group I was reassured of surgery at a later date. Instead the PTFE group had a lower recurrence (P = 0.91).
| Discussion|| |
Many hernia repair methods have been described. Traditional primary repair entails a laparotomy with suture approximation of strong fascial tissue on each side of the defect. However, recurrence rates after this procedure range from 41 to 52% during long-term follow-up.  Herniorrhaphies in which large prosthetic meshes are implanted appear to have lower failure rates (12-24%), but the required dissection of wide areas of soft tissue contributes to an increased incidence of wound infections and wound-related complications (12% or higher).  These problems have stimulated a continuing search for new techniques for repairing ventral hernias.
This study was part of a multi-centre trial for a follow up duration of one year. Because of Follow up was carried out in the out-patient department and on telephonic conversation. This was to avoid loss at follow-up. The study design varied significantly from other studies such as the exclusion of large size defects and inclusion of only midline incisional hernias. This was done to avoid confounding the results of surgery.
In a study conducted by Heniford et al.,  consecutive 100 cases were selected that was a larger figure in comparison to our study but included all dimensions of hernia, both incisional and non-incisional. This was excluded in the present study as was the large size defect.
Another study that was conducted by colon et al. included 116 consecutive patients and included that same meshes in comparison as in this study,  The results of their study concluded that the results of both meshes were similar and recommended individual preference for the use in repair of ventral hernias. From continuation of the ongoing trial and completion of their study and results the study was limited to 90 patients, in our study, being adequate from the frequency of recurrence published in their study.
Having discussed the similarity of the body mass index in the two groups in this study, it significantly differed from other western studies where the BMI was in excess of 35.  This was in contradiction to the fact that the recurrence rate in our study was slightly higher than in a study conducted by Novitsky et al.,  but the recurrence rate supported by a study by conducted by Heniford et al. was much lower, a meager 3 vs 8.8%. 
In other studies there was a tendency on behalf of the surgeon to choose a particular mesh and this was clearly limited in the present study. In a large trial of 819 patients over a nine year experience also failed to compare outcomes between the two meshes compared in this study. 
Hospital stay was higher in comparison to some studies such as 3.6 days even in obese patients in a study conducted by Raftopoulos et al.  whereas in a study by Heniford it was only 2.3 days a mean. Considering a large defect the length of stay documented by these studies remain an enigma to the emerging laparoscopic surgeons of this region, mean hospital stay 4.6 days with defects less than 10cm. the comparisons are intriguing also considering that the defects in this study was much smaller as documented by other studies.
In the above study the mean operating time was only 88 min that was much less than the time taken even in the polyester group that was 164 min. the time taken to fixation of mesh and time till adhesiolysis was not documented in other western studies ,,,,, to draw conclusions to the point in which surgeons in this study took longer time. This could be due to the nature of adhesion and using better energized vessel sealing devices in western countries. ,,
In the studies that did make comparison of the type of mesh, no significant difference was observed but the significantly higher rate of intestinal obstruction in patients receiving a polyester mesh does change some concepts. ,,,, Although none required a second surgery and settled on conservative surgery, caution to be observed can convincingly be depicted by conducting other studies with a longer follow up and meta-analysis.
In most studies and our study the mode of fixation was not uniform. This was inevitable as the patients from this study were also part of another study conducted for choice of fixation. , Whether the mode of fixation of the mesh or the material of mesh used has more importance, inferences from most studies confirm that greater the size of defect the more the chance of recurrence. ,,
Whether laparoscopic incisional hernia repair is safer and more effective than open repair is not yet known. Several series of laparoscopic incisional hernia repairs have been reported by North American and European researchers. The results show a marked consistency with respect to low peri-operative morbidity and low rates of hernia recurrence during follow-up. ,,
Other advantages of laparoscopic incisional hernia repair over open repair were cited but remain speculative. No recent studies comparing laparoscopic incisional hernia repair and open repair directly have been published. Nevertheless, this study has also indicated that laparoscopic incisional hernia repair may have advantages over the open procedure in regard to peri-operative complications, hospital stay, and hernia recurrences.
Although complications occurred less frequently in our series than in series of open herniorrhaphies, they remain an important consideration in laparoscopic incisional hernia repair. One of the most common complications we observed was symptomatic or prolonged seroma. Most seromas developed above the mesh and within the retained hernia sac, and many of our patients had them. The majority resolved spontaneously without intervention, but 11% of our patients continued to have a clinically apparent seroma for more than eight weeks postoperatively.
Regardless of whether the seromas were aspirated under sterile conditions or allowed to resolve, most did not cause any long-term problems. We recommend that surgeons discuss the possibility of a seroma with their patients preoperatively and, if one becomes clinically evident after surgery, that it be watched unless it causes discomfort or becomes persistent.
| Conclusion|| |
The frequency of recurrence was similar in both groups. A higher frequency of intestinal obstruction was observed in the polyester group that could limit its use for repair of ventral hernias but convincing evidence can be deduced from similar studies with longer follow up and meta-analysis. The use of polyester for the treatment should be considered with alternating the collagen type or a substance with better fibrinolytic properties.
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[Table 1], [Table 2]