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1.  Chronic Pain after Laparoscopic Transabdominal Preperitoneal Hernia Repair: A Randomized Comparison of Light and Extralight Titanized Polypropylene Mesh 
World Journal of Surgery  2010;35(2):302-310.
The aim of this prospective, randomized, single-blinded clinical trial was to compare the incidence of chronic pain after laparoscopic transabdominal preperitoneal hernia repair (TAPP) using a 35-g/m2 titanized polypropylene mesh and a 16-g/m2 titanized polypropylene mesh. The reported incidence of chronic pain in patients who underwent laparoscopic hernia repair is a serious problem. The techniques of dissection, mesh fixation, and the mesh material used have all been identified as being part of the problem. Excellent biocompatibility through a unique combination of a lightweight open porous polypropylene mesh covered with a covalent-bonded titanium layer has been claimed. The aim of this study was to find out whether the titanium surface alone or the difference in material load between the two available meshes influences clinical outcomes.
Three hundred eighty patients with 466 inguinal hernias were operated on between 2002 and 2006 with the laparoscopic transabdominal preperitoneal (TAPP) technique. Mesh fixation with staples was carried out routinely. After the dissection was completed just prior to the implantation of the mesh, patients were randomized into two groups. In Group A, 250 (53.6%) inguinal hernias were repaired with a 35-g/m2 titanized polypropylene mesh, and in Group B, 216 (46.4%) inguinal hernias were repaired with a 16-g/m2 titanized polypropylene mesh. The primary outcome was chronic pain 3 years after surgery. The degree of pain was determined using a visual analog scale (VAS) with a range from 0 to 10. The secondary outcome was the rate of recurrence.
The postoperative period of observation was at least 3 years for every patient. In both groups, 90% of the patients could be questioned and examined clinically: in Group A (Light), 5.3% of the patients and in Group B (Extralight), 1.5% of the patients suffered from chronic pain. Chronic pain was significantly more common in Group A than in Group B (p = 0.037). There was no difference with respect to the rate of recurrence: for Group A it was 3.1% and for Group B it was 2.6% (p = 0.724).
Chronic pain is not very common in patients who have had their inguinal hernias repaired with titanium-covered polypropylene mesh. Reducing the material load from 35 to 16 g/m2 seems to further improve the biocompatibility of these meshes, thus improving the clinical outcome by reducing chronic pain to a rare event. The role of staples in causing chronic pain following inguinal hernia repair may be overestimated. There was no evidence supporting the notion that the use of the 16-g/m2 titanized meshes is associated with increased recurrence rates.
PMCID: PMC3017304  PMID: 21103989
Hernia; Laparoscopy; TAPP; Pain; Titanized polypropylene mesh
2.  The Role of Fibrin Glue Polypropylene Mesh Fixation in Open Inguinal Hernia Repair 
Medical Archives  2014;68(2):90-93.
The aim:
of this study was to compare two methods of polypropylene mesh fixation for inguinal hernia repair according to Lichtenstein using fibrin glue and suture fixation.
Material and Methods:
The study included 60 patients with unilateral inguinal hernia, divided into two groups of 30 patients – Suture fixation and fibrin glue fixation.
All patients were analyzed according to:
age, gender, body mass index (BMI), indication for surgery–the type, localization and size of the hernia, preoperative level of pain and the type of surgery. Overall postoperative complications and the patient’s ability to return to regular activities were followed for 3 months.
Results and discussion:
Statistically significant difference in the duration of surgery, pain intensity and complications (p<0.05) were verified between method A, the group of patients whose inguinal hernia was repaired using polypropylene mesh–fibrin glue and method B, where inguinal hernia was repaired with polypropylene mesh using suture fixation. Given the clinical research, this systematic review of existing results on the comparative effectiveness, will help in making important medical decisions about options for surgical treatment of inguinal hernia.
The results of this study may impact decision making process for recommendations of methods of treatment by professional associations, making appropriate decisions on hospital procurement of materials, as well as coverage of health funds and insurance.
PMCID: PMC4272507  PMID: 24937929
inguinal hernia; fixation; fibrin glue; polypropylene mesh
3.  Study protocol for a randomized controlled trial for anterior inguinal hernia repair: transrectus sheath preperitoneal mesh repair compared to transinguinal preperitoneal procedure 
Trials  2013;14:65.
Anterior open treatment of the inguinal hernia with a tension-free mesh has reduced the incidence of hernia recurrence. The Lichtenstein procedure is the current reference technique for inguinal hernia treatment. Chronic pain has become the main postoperative complication after surgical inguinal hernia repair, especially following Lichtenstein. Preliminary experiences with a soft mesh positioned in the preperitoneal space (PPS) by transinguinal preperitoneal (TIPP) or total extraperitoneal (TEP) technique, showed promising results considering the reduction of postoperative chronic pain. Evolution of surgical innovations for inguinal hernia repair led to an open, direct approach with preperitoneal mesh position, such as TIPP. Based on the TIPP procedure, another preperitoneal repair has been recently developed, the transrectus sheath preperitoneal (TREPP) mesh repair.
The ENTREPPMENT trial is a multicentre randomized clinical trial. Patients will be randomly allocated to anterior inguinal hernia repair according to the TREPP mesh repair or TIPP procedure. All patients with a primary unilateral inguinal hernia, eligible for operation, will be invited to participate in the trial. The primary outcome measure will be the number of patients with postoperative chronic pain. Secondary outcome measures will be serious adverse events (SAEs), including recurrence, hemorrhage, return to daily activities (for example work), operative time and hospital stay. Alongside the trial health status, an economic evaluation will be performed. To demonstrate that inguinal hernia repair according to the TREPP technique reduces the percentage of patients with postoperative chronic pain from 12% to <6%, a sample size of 800 patients is required (two-sided test, α = 0.05, 80% power).The ENTREPPMENT trial aims to evaluate the TREPP and TIPP procedures from patients’ perspective. It is hypothesized that the TREPP technique may reduce the number of patients with any form of postoperative chronic pain by 50% compared to the TIPP procedure.
Trial registration
Current Controlled Trials: ISRCTN18591339
PMCID: PMC3598762  PMID: 23452397
Chronic pain; Inguinal; Hernia; Preperitoneal; Mesh; TREPP; TIPP; Open repair; Trial; Randomized
4.  Single-Incision Laparoscopic Intraperitoneal Onlay Mesh Repair for the Treatment of Multiple Recurrent Inguinal Hernias 
Despite an exponential rise in laparoscopic surgery for inguinal herniorrhaphy, overall recurrence rates have remained unchanged. Therefore, an increasing number of patients present with recurrent hernias after having failed anterior and laparoscopic repairs. This study reports our experience with single-incision laparoscopic (SIL) intraperitoneal onlay mesh (IPOM) repair for these hernias.
Materials and methods:
All patients referred with multiply recurrent inguinal hernias underwent SIL-IPOM from November 1 2009 to October 30 2013. A 2.5-cm infraumbilical incision was made and a SIL surgical port was placed intraperitoneally. Modified dissection techniques, namely, “chopsticks” and “inline” dissection, 5.5 mm/52 cm/30° angled laparoscope and conventional straight dissecting instruments were used. The peritoneum was incised above the symphysis pubis and dissection continued laterally and proximally raising an inferior flap, below a previous extraperitoneal mesh, while reducing any direct/indirect/femoral/cord lipoma before placement of antiadhesive mesh that was fixed into the pubic ramus as well as superiorly with nonabsorbable tacks before fixing its inferior border with fibrin sealant. The inferior peritoneal flap was then tacked back onto the mesh.
There were 9 male patients who underwent SIL-IPOM. Mean age was 55 years old and mean body mass index was 26.8 kg/m2. Mean mesh size was 275 cm2. Mean operation time was 125 minutes with hospital stay of 1 day and umbilical scar length of 21 mm at 4 weeks' follow-up. There were no intraoperative/postoperative complications, port-site hernias, chronic groin pain, or recurrence with mean follow-up of 20 months.
Multiply recurrent inguinal hernias after failed conventional anterior and laparoscopic repairs can be treated safely and efficiently with SIL-IPOM.
PMCID: PMC4154433  PMID: 25392643
Intraperitoneal onlay mesh repair; Multiply recurrent inguinal hernia; Single-incision laparoscopic surgery
5.  Inguinodynia following Lichtenstein tension-free hernia repair: A review 
Chronic Groin Pain (Inguinodynia) following inguinal hernia repair is a significant, though under-reported problem. Mild pain lasting for a few days is common following mesh inguinal hernia repair. However, moderate to severe pain persisting more than 3 mo after inguinal herniorrhaphy should be considered as pathological. The major reasons for chronic groin pain have been identified as neuropathic cause due to inguinal nerve(s) damage or non-neuropathic cause due to mesh or other related factors. The symptom complex of chronic groin pain varies from a dull ache to sharp shooting pain along the distribution of inguinal nerves. Thorough history and meticulous clinical examination should be performed to identify the exact cause of chronic groin pain, as there is no single test to confirm the aetiology behind the pain or to point out the exact nerve involved. Various studies have been performed to look at the difference in chronic groin pain rates with the use of mesh vs non-mesh repair, use of heavyweight vs lightweight mesh and mesh fixation with sutures vs glue. Though there is no convincing evidence favouring one over the other, lightweight meshes are generally preferred because of their lesser foreign body reaction and better tolerance by the patients. Identification of all three nerves has been shown to be an important factor in reducing chronic groin pain, though there are no well conducted randomised studies to recommend the benefits of nerve excision vs preservation. Both non-surgical and surgical options have been tried for chronic groin pain, with their consequent risks of analgesic side-effects, recurrent pain, recurrent hernia and significant sensory loss. By far the best treatment for chronic groin pain is to avoid bestowing this on the patient by careful intra-operative handling of inguinal structures and better patient counselling pre- and post-herniorraphy.
PMCID: PMC3080712  PMID: 21528050
Hernia; Lichtenstein repair; Chronic groin pain; Inguinodynia; Mesh hernia repair; Ilio-inguinal nerve; Iliohypogastic nerve; Genitofemoral nerve
6.  Surgical management of inguinal hernias at Bugando Medical Centre in northwestern Tanzania: our experiences in a resource-limited setting 
BMC Research Notes  2012;5:585.
Inguinal hernia repair remains the commonest operation performed by general surgeons all over the world. There is paucity of published data on surgical management of inguinal hernias in our environment. This study is intended to describe our own experiences in the surgical management of inguinal hernias and compare our results with that reported in literature.
A descriptive prospective study was conducted at Bugando Medical Centre in northwestern Tanzania. Ethical approval to conduct the study was obtained from relevant authorities before the commencement of the study. Statistical data analysis was done using SPSS software version 17.0.
A total of 452 patients with inguinal hernias were enrolled in the study. The median age of patients was 36 years (range 3 months to 78 years). Males outnumbered females by a ratio of 36.7:1. This gender deference was statistically significant (P = 0.003). Most patients (44.7%) presented late (more than five years of onset of hernia). Inguinoscrotal hernia (66.8%) was the commonest presentation. At presentation, 208 (46.0%) patients had reducible hernia, 110 (24.3%) had irreducible hernia, 84 (18.6%) and 50(11.1%) patients had obstructed and strangulated hernias respectively. The majority of patients (53.1%) had right sided inguinal hernia with a right-to-left ratio of 2.1: 1. Ninety-two (20.4%) patients had bilateral inguinal hernias. 296 (65.5%) patients had indirect hernia, 102 (22.6%) had direct hernia and 54 (11.9%) had both indirect and direct types (pantaloon hernia). All patients in this study underwent open herniorrhaphy. The majority of patients (61.5%) underwent elective herniorrhaphy under spinal anaesthesia (69.2%). Local anaesthesia was used in only 1.1% of cases. Bowel resection was required in 15.9% of patients. Modified Bassini’s repair (79.9%) was the most common technique of posterior wall repair of the inguinal canal. Lichtenstein mesh repair was used in only one (0.2%) patient. Complication rate was 12.4% and it was significantly higher in emergency herniorrhaphy than in elective herniorrhaphy (P = 0.002). The median length of hospital stay was 8 days and it was significantly longer in patients with advanced age, delayed admission, concomitant medical illness, high ASA class, the need for bowel resection and in those with surgical repair performed under general anesthesia (P < 0.001). Mortality rate was 9.7%. Longer duration of symptoms, late hospitalization, coexisting disease, high ASA class, delayed operation, the need for bowel resection and presence of complications were found to be predictors of mortality (P < 0.001).
Inguinal hernias continue to be a source of morbidity and mortality in our centre. Early presentation and elective repair of inguinal hernias is pivotal in order to eliminate the morbidity and mortality associated with this very common problem.
PMCID: PMC3526506  PMID: 23098556
Inguinal hernias; Surgical management; Treatment outcome; Predictors of outcome; Tanzania
7.  Assessment of Pain and Quality of Life in Lichtenstein Hernia Repair Using a New Monofilament PTFE Mesh: Comparison of Suture vs. Fibrin-Sealant Mesh Fixation 
Frontiers in Surgery  2014;1:45.
Background: Inguinal hernia repair is one of the most common operations in general surgery. The Lichtenstein tension-free operation has become the gold standard in open inguinal hernia repair. Despite the low recurrence rates, pain and discomfort remain a problem for a large number of patients. The aim of this study was to compare suture fixation vs. fibrin sealing by using a new monofilament PTFE mesh, i.e., the Infinit® mesh by W. L. Gore & Associates.
Methods: This study was designed as a controlled prospective single-center two-cohort study. A total of 38 patients were enrolled and operated in Lichtenstein technique either standard suture mesh fixation or fibrin-sealant mesh fixation were used as described in the TIMELI trial. Primary outcome parameters were postoperative complications with the new mesh (i.e., seroma, infection), pain, and quality of life evaluated by the VAS and the SF-36 questionnaire. Secondary outcome was recurrence assessed by ultrasound and physical examination. Follow-up time was 1 year.
Results: Significantly, less postoperative pain was reported in the fibrin-sealant group compared to the suture group at 6 weeks (P = 0.035), 6 months (P = 0.023), and 1 year (P = 0.011) postoperatively. Additionally, trends toward a higher postoperative quality of life, a faster surgical procedure, and a shorter hospital stay were seen in the fibrin-sealant group.
Conclusion: Fibrin-sealant mesh fixation in Lichtenstein hernioplasty effectively reduces acute and chronic postoperative pain. Monofilament, macro-porous, knitted PTFE meshes seem to be a practicable alternative to commonly used polypropylene meshes in open inguinal hernia repair.
PMCID: PMC4286975  PMID: 25593969
monofilament PTFE; Lichtenstein hernia repair; fibrin glue; postoperative pain; quality of life
8.  The Tilburg double blind randomised controlled trial comparing inguinal hernia repair according to Lichtenstein and the transinguinal preperitoneal technique 
Trials  2009;10:89.
Anterior open treatment of the inguinal hernia with a tension free mesh has reduced the incidence of recurrence and direct postoperative pain. The Lichtenstein procedure rules nowadays as reference technique for hernia treatment. Not recurrences but chronic pain is the main postoperative complication in inguinal hernia repair after Lichtenstein's technique. Preliminary experiences with a soft mesh placed in the preperitoneal space showed good results and less chronic pain.
The TULIP is a double-blind randomised controlled trial in which 300 patients will be randomly allocated to anterior inguinal hernia repair according to Lichtenstein or the transinguinal preperitoneal technique with soft mesh. All unilateral primary inguinal hernia patients eligible for operation who meet inclusion criteria will be invited to participate in this trial. The primary endpoint will be direct postoperative- and chronic pain. Secondary endpoints are operation time, postoperative complications, hospital stay, costs, return to daily activities (e.g. work) and recurrence. Both groups will be evaluated.
Success rate of hernia repair and complications will be measured as safeguard for quality.
To demonstrate that inguinal hernia repair according to the transinguinal preperitoneal (TIPP) technique reduces postoperative pain to <10%, with α = 0,05 and power 80%, a total sample size of 300 patients was calculated.
The TULIP trial is aimed to show a reduction in postoperative chronic pain after anterior hernia repair according to the transinguinal preperitoneal (TIPP) technique, compared to Lichtenstein.
In our hypothesis the TIPP technique reduces chronic pain compared to Lichtenstein.
Trial registration
ISRCTN 93798494
PMCID: PMC2761380  PMID: 19781069
9.  NiTiNol Hernia Device Stability in Inguinal Hernioplasty Without Fixation 
Radiographic analysis of a NiTiNol framed, polypropylene mesh hernia device when used for laparoscopic inguinal hernioplasty showed it to be stable with regard to size, shape and position six months after implantation.
Background and Objective:
To determine whether the NiTiNol frame of a novel hernia repair device utilizing polypropylene mesh for inguinal hernioplasty remains stable and intransient without fixation after a minimum of 6 months.
Twenty patients had 27 inguinal hernias repaired using a novel hernia repair device that has a NiTiNol frame without any fixation. Initial single-view, postoperative X-rays were compared with a second X-ray obtained at least 6 months later. The NiTiNol frame, which can be easily visualized on a plain X-ray, was measured in 2 dimensions, as were anatomic landmarks. The measurements obtained and the appearances of the 2 X-rays were compared to determine the percentage of change in device size and device stability with regard to device location and shape.
There were minimal changes noted between the 2 sets of measurements obtained with an overall trend towards a slight increase in the size of the hernia repair device. The devices demonstrated intransience of position and stability of shape.
The NiTiNol frame of a novel hernia repair device utilizing polypropylene mesh exhibits radiographic evidence of size and shape stability and intransience of position without fixation when used in inguinal hernioplasty after a minimum follow-up of 6 months.
PMCID: PMC3148863  PMID: 21902967
NiTiNol; Hernia; Shrinkage; Fixation
10.  Randomized clinical trial comparing inguinal hernia repair with Lichtenstein technique using non-absorbable or partially absorbable mesh. Preliminary report 
The Lichtenstein technique is currently considered the “gold standard” of open, anterior inguinal hernia repair. It is not free, however, of adverse effects, which may be caused by the implemented synthetic material.
Determination the influence of the mesh employed on treatment results including immediate complications, return to everyday activities, chronic pain occurrence and hernia recurrence.
Material and methods
Tension-free hernia repair using the Lichtenstein technique was performed in all the 59 patients randomized to trial groups. Group P with heavyweight polypropylene mesh contained 34 patients; group V with lightweight, partially absorbable mesh (polypropylene/polyglactin 910) consisted of 25 people. Controlled, scheduled follow-up appointments took place after the 7th day and the 3rd and 6th month. Patients were clinically assessed and pain intensity was determined on an analogue-visual scale.
No statistically significant influence of the type of mesh on the risk of early complications, severe pain intensity, the length of hospital stay, time of recovery, or patients’ satisfaction with treatment was observed. After 6 months also no statistically significant differences were observed between groups with regard to recurrence rate (P 3.4% vs. V 4.0%), chronic pain (P 5.9% vs. V 4.0%) and ailments such as “foreign body presence” (V vs. P, OR = 0.30, 95% CI 0.077-1.219, p = 0.093) incidence, although their probability was 70% lower for V mesh.
The preliminary results confirm the effectiveness of the Lichtenstein technique for hernia repair with both types of meshes. It appears that use of a partially absorbable mesh is connected with lower risk of postoperative complications, but the final results require multicentre trials in a larger series of patients.
PMCID: PMC3516947  PMID: 23255981
inguinal hernia; Lichtenstein technique; non-absorbable; partially absorbable mesh
11.  Health Technology Assessment of laparoscopic compared to conventional surgery with and without mesh for incisional hernia repair regarding safety, efficacy and cost-effectiveness 
Incisional hernias are a common complication following abdominal surgery and they represent about 80% of all ventral hernia. In uncomplicated postoperative follow-up they can develop in about eleven percent of cases and up to 23% of cases with wound infections or other forms of wound complications. Localisation and size of the incisional hernia can vary according to the causal abdominal scar. Conservative treatment (e. g. weight reduction) is only available to relieve symptoms while operative treatments are the only therapeutic treatment option for incisional hernia. Traditionally, open suture repair was used for incisional hernia repair but was associated with recurrence rates as high as 46%. To strengthen the abdominal wall and prevent the development of recurrences the additional implantation of an alloplastic mesh is nowadays commonly used. Conventional hernia surgery as well as minimally invasive surgery, introduced in the early 90s, make use of this mesh-technique and thereby showed marked reductions in recurrence rates. However, there are possible side effects associated with mesh-implantation. Therefore recommendations remain uncertain on which technique to apply for incisional hernia repair and which technique might, under specific circumstances, be associated with advantages over others.
The goal of this HTA-Report is to compare laparoscopic incisional hernia repair (LIHR) and conventional incisional hernia repair with and without mesh-implantation in terms of their medical efficacy and safety, their cost-effectiveness as well as their ethical, social und legal implications. In addition, this report aims to compare different techniques of mesh-implantation and mesh-fixation as well as to identify factors, in which certain techniques might be associated with advantages over
Relevant publications were identified by means of a structured search of databases accessed through the German Institute of Medical Documentation and Information (DIMDI) as well as by a manual search. The former included the following electronic resources:
SOMED (SM78), Cochrane Library – Central (CCTR93), MEDLINE Alert (ME0A), MEDLINE (ME95), CATFILEplus (CATLINE) (CA66), ETHMED (ED93), GeroLit (GE79), HECLINET (HN69), AMED (CB85), CAB Abstracts (CV72), GLOBAL Health (AZ72), IPA (IA70), Elsevier BIOBASE (EB94), BIOSIS Previews (BA93), EMBASE (EM95), EMBASE Alert (EA08), SciSearch (IS90), Cochrane Library – CDSR (CDSR93), NHS-CRD-DARE (CDAR94), NHS-CRD-HTA (INAHTA) as well as NHSEED (NHSEED).
The present report includes German and English literature published until 31.08.2005. The search parameters can be found in the appendix. No limits were placed on the target population. The methodological quality of the included clinical studies was assessed using the criteria recommended by the “Scottish Intercollegiate Guidelines Network Grading Review Group“. Economic studies were evaluated by the criteria of the German Scientific Working Group Technology Assessment for Health Care.
The literature search identified 17 relevant medical publications. One of these studies compared laparoscopic and conventional surgery with and without mesh for incisional hernia repair, while 16 studies compared laparoscopic and conventional surgery with mesh for incisional hernia repair. Among these studies were 14 primary studies (one randomised controlled trial (RCT), two systematic reviews and one HTA-Report. The only study comparing laparoscopic and conventional surgery without mesh found substantial differences in terms of baseline characteristics between treatment groups. The outcome parameters showed decreased recurrence rates for the laparoscopic repair and similar safety of the procedures. Studies comparing laparoscopic and conventional surgery with mesh found similar outcome in terms of medical efficacy and safety. However, there was a trend towards lower recurrence rates, length of hospital stay, and postoperative pain as well as decreased complication rates for laparoscopic repair in the majority of studies. The impact of the technique of mesh-implantation and -fixation as well as the impact of certain factors on the choice of technique has not been systematically assessed in any of the studies.
All identified studies suffer from significant methodological weaknesses, such as differences between treatment groups, mainly due to the non-randomised study design, small treatment groups causing low case numbers and lack of statistical power as well as the neglect of important risk factors or adjustment for those. Therefore, no conclusive differences could be identified concerning compared operative techniques, mesh-implantation and -fixation techniques or certain risk factors. Only the comparison of laparoscopic and conventional technique with mesh provides some evidence for a trend towards similar or slightly improved outcome in terms of medical efficacy and safety for the laparoscopic technique. However, there is still a great need for further research to investigate these questions.
Basically, there is no full economic evaluation focussing on the relevant alternatives. Cost compareisons were available, even though only briefly attached to clinical research results. None of the studies primarily aimed to investigate costs or even cost-effectiveness.
When deciding on the choice of operative technique for incisional hernia repair, surgeons take various considerations into account, including patient characteristics, hernia characteristics and their own experience. The studies included in this HTA did not provide conclusive evidence to answer the research questions. Nonetheless, laparoscopic surgery demonstrated a trend towards similar or slightly improved outcome following incisional hernia repair. However, for more conclusive recommendations on the choice of operative technique, high quality trials are required
From the economic perspective, alternative methods are not yet assessed. Only five of the studies involve a cost analysis, though in an insufficient manner. None of the studies identified were laid out as a health economic evaluation. Hence, further research is strongly recommended.
PMCID: PMC3011306  PMID: 21289907
12.  Inguinal hernia repair using a synthetic long-term resorbable mesh: results from a 3-year prospective safety and performance study 
Hernia  2014;18(5):723-730.
Conventional meshes for hernia repair and abdominal wall reinforcement are usually made from polypropylene, polyester or other synthetic plastic materials known to promote foreign body reactions and a state of chronic inflammation that may lead to long-term complications. A novel approach is to use long-term resorbable implants like TIGR® Matrix Surgical Mesh. Preclinical studies have shown that this mesh maintains mechanical integrity beyond the point in time where newly formed tissue is capable of carrying the abdominal loads.
This was a first-in-man, prospective, pilot study performed during 2009, at two sites in Sweden. Forty patients with primary inguinal hernias were enrolled for Lichtenstein repair using TIGR® Matrix Surgical Mesh. The primary endpoint was safety as assessed by monitoring the incidence of adverse events and serious adverse events (SAEs) both related and unrelated to the mesh. The secondary endpoint was pain or discomfort. Visual Analogue Scale (VAS) 0–10 and Inguinal Pain Questionnaire were used for scoring pain and discomfort. Included patients have been followed for 36 months using ultrasound in combination with clinical examination.
All patients followed a normal early postoperative course. After 12 months no SAEs were reported. None of the patients with an isolated lateral inguinal hernia (LIH) had developed a recurrence but 4 (44 %) with medial and 4 (33 %) with combined hernias had recurred at 36-month follow-up. After 3-year follow-up none of the patients with LIH reported pain in the VAS-form and none of those patients could feel the sensation of a mesh in their groin. In the total study population 5 (16 %) patients experienced chronic pain in the form of mild sporadic pain and 3 (9.7 %) patients could feel the sensation of a mesh in their groin.
The use of a synthetic long-term resorbable mesh (TIGR® Matrix Surgical Mesh) in Lichtenstein repair was found to be safe, without recurrences, and promising regarding pain/discomfort at 3-year follow-up in patients with LIH. However, patients with medial and combined inguinal hernias had high recurrence rates.
PMCID: PMC4177566  PMID: 24770701
Hernia; Absorbable implant; Surgical mesh; Recurrence; Indirect inguinal hernia; Chronic pain
13.  Open tension free repair of inguinal hernias; the Lichtenstein technique 
BMC Surgery  2001;1:3.
Recurrences have been a significant problem following hernia repair. Prosthetic materials have been increasingly used in hernia repair to prevent recurrences. Their use has been associated with several advantages, such as less postoperative pain, rapid recovery, low recurrence rates.
In this retrospective study, 540 tension-free inguinal hernia repairs were performed between August 1994 and December 1999 in 510 patients, using a polypropylene mesh (Lichtenstein technique). The main outcome measure was early and late morbidity and especially recurrence.
Inguinal hernia was indirect in 55 % of cases (297 patients), direct in 30 % (162 patients) and of the pantaloon (mixed) type in 15 % (81 patients). Mean patient age was 53.7 years (range, 18 – 85). Follow-up was completed in 407 patients (80 %) by clinical examination or phone call. The median follow-up period was 3.8 years (range, 1 – 6 years). Seroma and hematoma formation requiring drainage was observed in 6 and 2 patients, respectively, while transient testicular swelling occurred in 5 patients. We have not observed acute infection or abscess formation related to the presence of the foreign body (mesh). In two patients, however, a delayed rejection of the mesh occurred 10 months and 4 years following surgery. There was one recurrence of the hernia (in one of these patients with late mesh rejection) (recurrence rate = 0.2 %). Postoperative neuralgia was observed in 5 patients (1 %).
Lichtenstein tension-free mesh inguinal hernia repair is a simple, safe, comfortable, effective method, with extremely low early and late morbidity and remarkably low recurrence rate and therefore it is our preferred method for hernia repair since 1994.
PMCID: PMC59657  PMID: 11696246
14.  A Systematic Review of Outcomes Following Repair of Complex Ventral Incisional Hernias With Biologic Mesh 
International Surgery  2013;98(4):399-408.
Repair of contaminated/infected ventral incisional hernias is marked by high rates of recurrence, complications, and/or explantation of synthetic mesh. Biologic mesh products are recommended for repair to permit reconstruction and reduce complications. A systematic review of PubMed, EMBASE, and Cochrane databases identified English-language articles reporting postoperative outcomes (e.g., hernia recurrence, infection, mesh explantation) in patients undergoing contaminated/infected ventral incisional herniorrhaphy. Eleven studies met inclusion criteria and contained quantitative outcome data. All were retrospective chart reviews of biologic mesh use (mostly human acellular dermal matrix). Hernia recurrence and wound infection rates were highly variable and inconsistently reported across studies. Mesh explantation was rarely reported. Outcome variability is likely owing to heterogenous patient populations, surgical technique variations, and follow-up duration. Biologic mesh use in contaminated/infected herniorrhaphy was marked by low reported rates of secondary surgeries for infected mesh removal. Data from large, well-controlled, prospective trials with biologic mesh products are needed.
PMCID: PMC3829071  PMID: 24229031
Ventral incisional herniorrhaphy; Biologic mesh; Hernia recurrence; Postsurgical complication
15.  Laparoscopic Repair of Inguinal Hernia Using Surgisis Mesh and Fibrin Sealant 
We tested the hypothesis that laparoscopic inguinal herniorrhaphy using Surgisis mesh secured with fibrin sealant is an effective long-term treatment for repair of inguinal hernia. This case series involved 38 adult patients with 51 inguinal hernias treated in a primary care center.
Between December 2002 and May 2005, 38 patients with 45 primary and 6 recurrent inguinal hernias were treated with laparoscopic repair by the total extra-peritoneal mesh placement (TEP) technique using Surgisis mesh secured into place with fibrin sealant. Postoperative complications, incidence of pain, and recurrence were recorded, as evaluated at 2 weeks, 6 weeks, 1 year, and with a follow-up questionnaire and telephone interview conducted in May and June 2005.
The operations were successfully performed on all patients with no complications or revisions to an open procedure. Average follow-up was 13 months (range, 1 to 30). One hernia recurred (second recurrence of unilateral direct hernia), indicating a 2% recurrence rate.
Laparoscopic repair of inguinal hernia using Surgisis mesh secured with fibrin sealant can be effectively used to treat primary, recurrent, direct, indirect, and bilateral inguinal hernias in adults without complications and minimal recurrence within 1-year of follow-up.
PMCID: PMC3015740  PMID: 17575758
Inguinal hernia; Laparoscopy; TEP repair; Surgisis mesh; Fibrin glue
16.  Guidelines for inguinal hernia repair in everyday practice. 
BACKGROUND: The Royal College of Surgeons of England published clinical guidelines for the management of groin hernia in adults in July 1993. We compared our indications, techniques, complications and outcome with these guidelines. PATIENTS AND METHODS: A consecutive series of 440 patients who underwent a groin hernia repair from the 1 July 1994 to 30 July 1995 were studied retrospectively. Special consideration was given to the advantages and acceptance of day-case surgery. Confidential questionnaires were sent to all patients 6-12 months following surgery. RESULTS: The majority of elective primary inguinal hernias (83%) were repaired by the open tension-free Lichtenstein mesh technique. Our selection criteria for day-case surgery included ASA I, age (< 65 years) and social situation; 56% underwent an operation on a day-case basis. Including in-patients discharged within 24 h following operation, this proportion of 'day-cases' increased to 72.5%. Less complications occurred in the day-case group (P = 0.018). However, this difference may be caused by incomplete reporting of complications in the day-case group. There were no significant differences in patients' satisfaction, postoperative attendance for medical advice or time back to work between the day-case and in-patient group. CONCLUSIONS: The guidelines need to be reviewed. The Lichtenstein repair offers an excellent and simple technique for hernia repair as a day-case procedure. Our results suggest that the number of hernia repairs performed as a day-case could substantially be increased to more than the recommended 30%. Time off work is mainly influenced by the advice given by GPs and surgeons. Reducing time off work by giving more appropriate recommendations and increasing the number of day-case surgery cases could significantly reduce the costs of health-care.
PMCID: PMC2503569  PMID: 11432143
17.  Outcomes of a prospective multi-center trial of a second-generation composite mesh for open ventral hernia repair 
Hernia  2013;18(1):81-89.
Composite mesh prostheses incorporate properties of multiple materials for use in open ventral hernia repair (OVHR). This study examines clinical outcomes in patients who underwent OVHR with a polypropylene/expanded polytetrafluoroethylene (ePTFE) composite graft containing a novel polydioxanone (PDO) absorbable ring to facilitate placement and graft positioning.
Data were prospectively collected on consecutive patients undergoing OVHR using a synthetic composite mesh. Seven centers enrolled patients during the study period. All patients underwent a standardized surgical procedure consisting of OVHR with sublay intraperitoneal placement of mesh. Mesh fixation was accomplished with peripheral tacks and transfascial sutures.
One hundred and nineteen patients underwent OVHR with the composite mesh. Average age was 55.8 years; there were 71 (59.7 %) females and 48 (40.3 %) males with mean BMI of 33.5 ± 7.1 kg/m2. One hundred and two (85.7 %) patients presented with primary ventral hernias. Mean defect size was 13.6 cm2, and mean mesh size was 113.6 cm2. Most patients (67 %) were discharged the day of surgery. Twelve patients (10.1 %) experienced complications in the perioperative time period primarily consisting of seroma (4.2 %) and ileus (1.7 %). Two patients required reoperation and mesh removal in the early postoperative period for infection and herniorrhaphy site pain, respectively. There was a decline in pain and movement limitation scores between baseline and 1-year follow-up. Six-month (n = 109) and twelve-month (n = 99) follow-up revealed no hernia recurrences (95 % CI 0–3 %, and 0–4 %, respectively).
The use of this second-generation composite mesh was associated with no hernia recurrences and a low complication rate after open ventral hernia repair.
PMCID: PMC3902081  PMID: 23526091
Ventral hernia repair; Composite mesh; Outcomes
18.  The transrectus sheath preperitoneal mesh repair for inguinal hernia: technique, rationale, and results of the first 50 cases 
Hernia  2011;16(3):295-299.
Laparoscopic and endoscopic hernia repair popularized the preperitoneal mesh position due to promising results concerning less chronic pain. However, considerable proportions of severe adverse events, learning curves, or added costs have to be taken into account. Therefore, open preperitoneal mesh techniques may have more advantages. The open approach to the preperitoneal space (PPS) according to transrectus sheath preperitoneal (TREPP) mesh repair is through the sheath of the rectus abdominus muscle. This technique provides an excellent view of the PPS and facilitates elective or acute hernia reduction and mesh positioning under direct vision. In concordance with the promising transinguinal preperitoneal inguinal hernia repair experiences in the literature, we investigated the feasibility of TREPP.
A rationale description of the surgical technique, available level of evidence for thoughts behind technical considerations. Furthermore, a descriptive report of the clinical outcomes of our pilot case series including 50 patients undergoing the TREPP mesh repair.
A consecutive group of our first 50 patients were operated with the TREPP technique. No technical problems were experienced during the development of this technique. No conversions to Lichtenstein repair were necessary. No recurrences and no chronic pain after a mean follow-up of 2 years were notable findings.
This description of the technique shows that the TREPP mesh repair might be a promising method because of the complete preperitoneal view, the short learning curve, and the stay-away-from-the-nerves principle. The rationale of the TREPP repair is discussed in detail.
PMCID: PMC3360865  PMID: 22131008
Inguinal hernia; Preperitoneal; Open; Repair; Mesh; Posterior
19.  Chronic groin pain following lichtenstein mesh hernioplasty for inguinal hernia. Is it a myth? 
The Indian Journal of Surgery  2009;71(2):84-88.
The Lichtenstein mesh hernioplasty is currently the most popular operative technique for open repair of inguinal hernia. The incidence of chronic groin pain (CGP) following this procedure is reported to be high. However, since our experience did not support this observation, this study was undertaken at our centre, to assess the incidence of CGP following Lichtenstein mesh hernioplasty.
A prospective study was conducted on all patients undergoing elective hernia repair at a tertiary care teaching hospital. The patients underwent Lichtenstein mesh hernioplasty and were followed up for the primary outcome measures of development of recurrence and Chronic Groin Pain.
A total of 470 patients were enrolled for the study. Out of these 16 patients never reported for follow up after discharge from hospital. The remaining 454 patients with 510 primary inguinal hernias were included in the study. Of these 449 patients were male and 5 were female. The mean follow-up period was 14 months (range — six months to twenty four months). One patient had recurrence of hernia and CGP was reported in four patients. In all four patients CGP was mild and was well controlled with oral NSAIDS used on SOS basis.
The incidence of CGP in our study is 0.78% for the number of operated hernias. This is not only considerably less than what is generally reported but is also less disabling.
PMCID: PMC3452605  PMID: 23133121
Chronic Groin Pain; Lichtenstein Mesh Hernioplasty
20.  Laparoscopic inguinal hernia repair: a prospective evaluation at Eastern Nepal 
Inguinal hernias have been treated traditionally with open methods of herniorrhaphy or hernioplasty. But the trends have changed in the last decade with the introduction of minimal access surgery.
This study was a prospective descriptive study in patients presenting to Surgery Department of B. P. Koirala Institute of Health Sciences, Dharan, Nepal with reducible inguinal hernias from January 2011 to June 2012. All patients >18 years of age presenting with inguinal hernias were given the choice of laparoscopic repair or open repair. Those who opted for laparoscopic repair were included in the study.
There were 50 patients, age ranged from 18 to 71 years with 34 being median age at presentation. In 41 patients, totally extraperitoneal repair was attempted. Of these, 2 (4%) repairs were converted to transabdominal repair and 2 to open mesh repair (4%). In 9 patients, transabdominal repair was done. The median total hospital stay was 4 days (range 3-32 days), the mean postoperative stay was 3.38±3.14 days (range 2-23 days), average time taken for full ambulation postoperatively was 2.05±1.39 days (range 1-10 days), and median time taken to return for normal activity was 5 days (range 2-50 days). One patient developed recurrence (2%). None of the patients who had laparoscopic repair completed complained of neuralgias in the follow-up.
Laparoscopic repair of inguinal hernias could be contemplated safely both via totally extra peritoneal as well as transperitoneal route even in our setup of a developing country with modifications.
PMCID: PMC4145269  PMID: 25170385
Extraperitoneal repair; transabdominal approach; seroma; inguinal hernia; laparoscopy
21.  Which mesh for hernia repair? 
The concept of using a mesh to repair hernias was introduced over 50 years ago. Mesh repair is now standard in most countries and widely accepted as superior to primary suture repair. As a result, there has been a rapid growth in the variety of meshes available and choosing the appropriate one can be difficult. This article outlines the general properties of meshes and factors to be considered when selecting one.
We performed a search of the medical literature from 1950 to 1 May 2009, as indexed by Medline, using the PubMed search engine (). To capture all potentially relevant articles with the highest degree of sensitivity, the search terms were intentionally broad. We used the following terms: ‘mesh, pore size, strength, recurrence, complications, lightweight, properties’. We also hand-searched the bibliographies of relevant articles and product literature to identify additional pertinent reports.
The most important properties of meshes were found to be the type of filament, tensile strength and porosity. These determine the weight of the mesh and its biocompatibility. The tensile strength required is much less than originally presumed and light-weight meshes are thought to be superior due to their increased flexibility and reduction in discomfort. Large pores are also associated with a reduced risk of infection and shrinkage. For meshes placed in the peritoneal cavity, consideration should also be given to the risk of adhesion formation. A variety of composite meshes have been promoted to address this, but none appears superior to the others. Finally, biomaterials such as acellular dermis have a place for use in infected fields but have yet to prove their worth in routine hernia repair.
PMCID: PMC3025220  PMID: 20501011
Hernia; Mesh; Filament; Tensile strength; Porosity; Acellular dermi
22.  Histologic and biomechanical evaluation of a novel macroporous polytetrafluoroethylene knit mesh compared to lightweight and heavyweight polypropylene mesh in a porcine model of ventral incisional hernia repair 
Hernia : the journal of hernias and abdominal wall surgery  2011;15(4):10.1007/s10029-011-0787-z.
To evaluate the biocompatibility of heavyweight polypropylene (HWPP), lightweight polypropylene (LWPP), and monofilament knit polytetrafluoroethylene (mkPTFE) mesh by comparing biomechanics and histologic response at 1, 3, and 5 months in a porcine model of incisional hernia repair.
Bilateral full-thickness abdominal wall defects measuring 4 cm in length were created in 27 Yucatan minipigs. Twenty-one days after hernia creation, animals underwent bilateral preperitoneal ventral hernia repair with 8 × 10 cm pieces of mesh. Repairs were randomized to Bard®Mesh (HWPP, Bard/Davol,, ULTRAPRO® (LWPP, Ethicon,, and GORE®INFINIT Mesh (mkPTFE, Gore & Associates, Nine animals were sacrificed at each timepoint (1, 3, and 5 months). At harvest, a 3 × 4 cm sample of mesh and incorporated tissue was taken from the center of the implant site and subjected to uniaxial tensile testing at a rate of 0.42 mm/s. The maximum force (N) and tensile strength (N/cm) were measured with a tensiometer, and stiffness (N/mm) was calculated from the slope of the force-versus-displacement curve. Adjacent sections of tissue were stained with hematoxylin and eosin (H&E) and analyzed for inflammation, fibrosis, and tissue ingrowth. Data are reported as mean ± SEM. Statistical significance (P < 0.05) was determined using a two-way ANOVA and Bonferroni post-test.
No significant difference in maximum force was detected between meshes at any of the time points (P > 0.05 for all comparisons). However, for each mesh type, the maximum strength at 5 months was significantly lower than that at 1 month (P < 0.05). No significant difference in stiffness was detected between the mesh types or between timepoints (P > 0.05 for all comparisons). No significant differences with regard to inflammation, fibrosis, or tissue ingrowth were detected between mesh types at any time point (P > 0.09 for all comparisons). However, over time, inflammation decreased significantly for all mesh types (P < 0.001) and tissue ingrowth reached a slight peak between 1 and 3 months (P = 0.001) but did not significantly change thereafter (P > 0.09).
The maximum tensile strength of mesh in the abdominal wall decreased over time for HWPP, LWPP, and mkPTFE mesh materials alike. This trend may actually reflect inability to adequately grip specimens at later time points rather than any mesh-specific trend. Histologically, inflammation decreased with time (P = 0.000), and tissue ingrowth increased (P = 0.019) for all meshes. No specific trends were observed between the polypropylene meshes and the monofilament knit PTFE, suggesting that this novel construction may be a suitable alternative to existing polypropylene meshes.
PMCID: PMC3826829  PMID: 21279663
Polypropylene; Knit polytetrafluoroethylene; Ventral hernia repair; Biomechanical evaluation; Histologic response; Tissue remodeling
23.  Post-operative benefits of Tisseel®/Tissucol® for mesh fixation in patients undergoing Lichtenstein inguinal hernia repair: secondary results from the TIMELI trial 
Hernia  2014;18(5):751-760.
The Tisseel/Tissucol for mesh fixation in Lichtenstein hernia repair (TIMELI) study showed that mesh fixation with human fibrin sealant during inguinal hernia repair significantly reduced moderate–severe complications of pain 12 months post-operatively compared with sutures. Further analyses may assist surgeons by investigating predictors of post-surgical complications and identifying patients that may benefit from Tisseel/Tissucol intervention.
Univariate and multivariate analyses identified risk factors for combined pain, numbness and groin discomfort (PND) visual analogue scale (VAS) score 12 months post-operatively. Variables tested were: fixation method, age, employment status, physical activity, nerve handling, PND VAS score at pre-operative visit and 1 week post-operatively. The effect of fixation technique on separate PND outcomes 12 months post-surgery was also assessed. Analyses included the intention-to-treat (ITT) population and a subpopulation with pre-operative PND VAS > 30 mm.
316 patients were included in the ITT, with 130 patients in the subpopulation with pre-operative PND VAS > 30. Multivariate analysis identified mesh fixation with sutures, worsening pre-operative PND and worsening PND 1 week post-surgery as significant predictors of 12-month PND in the ITT population; mesh fixation with sutures was a significant predictor of 12-month PND in the pre-operative PND VAS > 30 subpopulation (p < 0.05). Mesh fixation with Tisseel/Tissucol resulted in significantly less numbness and a lower intensity of groin discomfort compared with sutures at 12 months; there was no difference in pain between the treatment groups.
Pre-operative discomfort may be an important predictor of post-operative pain, numbness and discomfort. Tisseel/Tissucol may improve long-term morbidity over conventional sutures in these patients.
PMCID: PMC4177565  PMID: 24889273
Inguinal hernia repair; Mesh fixation; Lichtenstein technique; Chronic pain; Chronic numbness; Chronic groin discomfort
24.  Proceed™ Mesh for Laparoscopic Ventral Hernia Repair 
A laparoscopic approach to ventral hernia repair using Proceed mesh was associated with low conversion rate and no major complications in this study of single surgeon's experience.
Background and Objectives:
Laparoscopic technique to repair ventral hernia offers advantages over conventional open surgery such as shorter recovery time, decreased pain, and lower recurrence rates. There are a myriad of meshes available for laparoscopic repair of ventral hernias. This study evaluated the outcomes of laparoscopic repair of ventral hernias with Proceed mesh (Ethicon, Somerville, NJ, USA) in a single academic institution.
An institutional review board–approved retrospective review was performed for 100 consecutive patients with ventral hernia who underwent a laparoscopic approach at our institution from August 2006 to February 2009. All patients were operated on by a single surgeon using a standard technique with transabdominal suture fixation and tacks.
The study included 100 consecutive patients (57 female and 43 male patients). The mean age was 55 years (range, 16–78 years), and the mean body mass index was 33.3 kg/m2 (range, 19.6–68.9 kg/m2). Of the repairs, 27% were performed for a recurrent hernia. The mean and median size of the defect were 128 cm2 and 119.5 cm2 (range, 4–500 cm2), respectively. To ensure appropriate mesh overlap, the mean size of mesh was 253 cm2 (range, 36–700 cm2). There were 4 conversions. The mean operative time was 117 minutes (range, 35–286 minutes). The mean length of stay was 1.9 days. There were no major abdominal complications. With a mean follow-up period of 50 months (range, 38–68 months), we have not recorded any recurrences. No mesh-related complications have been documented.
The laparoscopic approach to ventral hernia repairs using Proceed mesh is associated with a low conversion rate and no major complications. At 50 months of follow-up, the recurrence rate is 0%. There were no mesh-related complications.
PMCID: PMC3866060  PMID: 24398198
Hernia; Laparoscopic; Ventral Hernia; Proceed; Mesh
25.  A Critical Review of Biologic Mesh Use in Ventral Hernia Repairs under Contaminated Conditions 
We used an evidence-based approach to determine if the promotions and claims of superiority of biologic mesh over synthetic mesh use in ventral hernia repairs (VHRs) under contaminated conditions were sound and valid.
We searched the Medline database to specifically identify review articles relating to biologic mesh and VHR and critically reviewed these studies using an evidence-based approach.
For the past forty-five years, four clinical reviews and one systematic review have included biologic meshes as part of a larger discussion on available prosthetics for VHR. All reviews supported biologic mesh use, especially in the setting of contaminated fields. Yet the primary literature included in these reviews and served as the basis for these conclusions consisted entirely of case series and case reports, which have the lowest level of evidence in determining scientific validity. Furthermore the FDA has neither cleared nor approved this particular use.
The cumulative data regarding biologic mesh use in VHRs under contaminated conditions does not support the claim that it is better than synthetic mesh used under the same conditions. The highly promoted and at least moderately utilized practice of placing biologic mesh in contamination is being done outside of the original intended use, and a re-evaluation of or possible moratorium on biologic mesh use in hernia surgery is seriously warranted. Alternatively, an industry-sponsored national registry of patients in whom ventral hernia repairs involved biologic mesh would substantively add to our understanding regarding how these intriguing biomaterials are being used and their overall clinical efficacy.
PMCID: PMC3601571  PMID: 23296600
hernia; incisional; mesh; prosthesis; mesh

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