Slowly resorbable biosynthetic mesh: 2-year results in VHWG grade 3 hernia repair

Introduction

Information on the long-term performance of biosynthetic meshes is scarce. This study analyses the performance of biosynthetic mesh (Phasix?) over 24 months.

Methods

A prospective, international European multi-center trial is described. Adult patients with a Ventral Hernia Working Group (VHWG) grade 3 incisional hernia larger than 10 cm², scheduled for elective repair, were included. Biosynthetic mesh was placed in sublay position. Short-term outcomes included 3-month surgical site occurrences (SSO), and long-term outcomes comprised hernia recurrence, reoperation, and quality of life assessments until 24 months.

Results

Eighty-four patients were treated with biosynthetic mesh. Twenty-two patients (26.2%) developed 34 SSOs, of which 32 occurred within 3 months (primary endpoint). Eight patients (11.0%) developed a hernia recurrence. In 13 patients (15.5%), 14 reoperations took place, of which 6 were performed for hernia recurrence (42.9%), 3 for mesh infection (21.4%), and in 7 of which the mesh was explanted (50%). Compared to baseline, quality of life outcomes showed no significant difference after 24 months. Despite theoretical resorption, 10.7% of patients reported presence of mesh sensation in daily life 24 months after surgery.

Conclusion

After 2 years of follow-up, hernia repair with biosynthetic mesh shows manageable SSO rates and favorable recurrence rates in VHWG grade 3 patients. No statistically significant improvement in quality of life or reduction of pain was observed. Few patients report lasting presence of mesh sensation. Results of biosynthetic mesh after longer periods of follow-up on recurrences and remodeling will provide further valuable information to make clear recommendations.

Trial registration

Registered on clinicaltrials.gov (NCT02720042), March 25, 2016.

     

Inguinal hernia: open surgical repair using mesh

Inguinal hernia repair is one of the most commonly performed procedures in general surgery. With the introduction of mesh, tissue herniorrhaphy was largely supplanted and open-mesh repair emerged as the gold standard. Innovation in biotechnology and surgical technique has resulted in the development of several varieties of mesh, as well as different approaches to mesh inguinal herniorrhaphy. Prior to performing open-mesh inguinal herniorrhaphy, the well-informed surgeon must be comfortable selecting the surgical option that is best suited for the clinical scenario and the surgeon's expertise.     

Laparoscopic slit mesh repair of parastomal hernia using a designated mesh: long-term results

Background  

Parastomal hernia (PH) is a frequent complication of colorectal surgery, which incidence reaches 55% of all stoma formation. Currently, there is no definitive strategy for its repair. This study was designed to assess the outcome in patients who underwent laparoscopic PH repair using a slit mesh/keyhole technique.     

Inguinal hernia repair with porcine small intestine submucosa: 3-year follow-up results of a randomized controlled trial of Lichtenstein's repair with polypropylene mesh versus Surgisis Inguinal Hernia Matrix

Background

The aim of this study was to evaluate the safety and efficacy of Lichtenstein's hernioplasty using Surgisis Inguinal Hernia Matrix (SIHM; Cook, Bloomington, Indiana) compared with polypropylene (PP; Angiologica, Pavia, Italy).

Methods

This was a prospective, randomized, double-blind trial comparing Lichtenstein's inguinal hernioplasty using SIHM versus PP.

Results

Seventy male patients underwent Lichtenstein's hernioplasty (n = 35 in the SIHM group and n = 35 in the PP group). At 3 years after surgery, there were 2 deaths (5.7%) in the PP group and 1 death (2.9%) in the SIHM group (not significant [NS]). Although the study was underpowered to evaluate the recurrence rate, only 1 recurrence (2.9%) was seen in the PP group (NS). Although a significant decrease in postsurgical pain incidence was never observed among patients in the SIHM group, a significantly lower degree of pain was detected at rest and on coughing at 1, 3, and 6 months and on movement at 1, 3, and 6 months and 1, 2, and 3 years. A significant decrease in postsurgical incidence and degree of discomfort when coughing and moving were observed among patients in the SIHM group at 3 and 6 months and at 1, 2, and 3 years after surgery.

Comments

SIHM hernioplasty seems to be a safe and effective procedure.     

Laparoscopic preperitoneal inguinal hernia repair using preformed polyester mesh without fixation: prospective study with 1-year follow-up results in a rural setting

BACKGROUND: To review our case series regarding the effectiveness, postprocedure pain, and cost of totally extraperitoneal (TEP) procedure for inguinal hernia repair, using a preformed polyester mesh (PEM), without fixation with additional anchoring devices. METHODS: Prospective evaluation of all patients from March 2001 to July 2005 who underwent the above-described procedure in an outpatient setting in the rural southern United States using a preformed anatomic Parietex PEM with a minimum 1-year follow-up. All patients were evaluated at 1, 3-week, and 1-year postprocedure for recurrence, complications, and pain level assessment using a standardized questionnaire employing visual analog scale. RESULTS: A series of 108 patients consisting of 95 males and 13 females were operated on with a total of 157 hernias being repaired using laparoscopic techniques. The 1-year follow-up rate was 88.9% (n=96/108). Only 1 followed-up patient (n=1/96; 1.04%) or 0.71% (n=1/140) followed-up hernia repair had a recurrence after TEP repair noted at 1-week postoperative. Two patients had temporary urinary retention and there were no infectious complications or readmissions to the hospital. Visual analog scale pain score (0 to 10) at 1-month postprocedure averaged 0.37 and decreased to 0.03 at 1 year. The cost difference in our institution for all non-reusable material used in laparoscopic hernia repair was US $ 116.77 more than for an open procedure. This was primarily caused by higher costs for the laparoscopic mesh. CONCLUSIONS: Laparoscopic TEP inguinal hernia repair with preformed PEM without additional fixation can be performed in a rural community hospital setting with minimal long-term postoperative pain and the procedure results are comparable with larger centers with only marginally increased costs over open hernia repair.     

Technique of parastomal hernia repair using synthetic mesh

We describe a reliable and simple technique of parastomal hernia repair using primary fascial repair with synthetic mesh that minimizes the known complications of infection and stomal stenosis while eliminating the need for peritoneal exploration, lysis of adhesions, and relocation of the stoma. We applied this technique to 6 patients (aged 65 to 83 years) with symptomatic, first-time parastomal hernias. The results are discussed.     

Inguinal hernia repair with beta glucan-coated mesh: results at two-year follow up

In a prospective study, 115 patients with a mean age of 55 years, presenting a primary or recurrent hernia were treated with a beta glucan-coated polypropylene mesh (Glucamesh). Fifty-eight underwent a Lichtenstein procedure and 57 had a laparoscopic procedure (TEP/TAPP). Oat beta glucan is an entirely natural plant product that eliminates the risk of viral or prion contamination associated with the use of collagen of animal origin. The beta glucan coated mesh is of lower weight and profile compared to a typical polypropylene implant. Preliminary results have been previously reported. With a mean follow up of 2 years, patients were evaluated by a physician and or a standardized questionnaire in order to evaluate the incidence rate of recurrence discomfort and residual chronic pain. One hundred nine (94.7%) questionnaires were returned. Of these, 104 (90.4%) were complete and analyzed. Mean follow up was 24 months (21–27). Two years after operation the recurrence rate was 1.9% (two cases: one in each group); 98 patients (94.2%) had no pain and have returned to normal activity, work and sport. Five patients (4.8%) had mild pain on moving or at rest and one (0.96%) had moderate pain at rest. There was no correlation between pain and hernia type or surgical technique. At 2 years follow up hernia repair with beta-glucan coated mesh has a low recurrence rate. Incidence of chronic pain is low. The situation is in relationship with a lightweight and smooth mesh of polypropylene and the role of oat beta glucan optimizing the healing and inclusion of the mesh into the tissues.     

Laparoscopic versus open ventral hernia mesh repair: a prospective study

Background An incisional hernia develops in 3% to 13% of laparotomy incisions, with primary suture repair of ventral hernias yielding unsatisfactory results. The introduction of a prosthetic mesh to ensure abdominal wall strength without tension has decreased the recurrence rate, but open repair requires significant soft tissue dissection in tissues that are already of poor quality as well as flap creation, increasing complication rates and affecting the recurrence rate. A minimally invasive approach was applied to the repair pf ventral hernias, with the expectation of earlier recovery, fewer postoperative complications, and decreased recurrence rates. This prospective study was performed to objectively analyze and compare the outcomes after open and laparoscopic ventral hernia repair. Methods The outcomes for 50 unselected patients who underwent laparoscopic ventral hernia repair were compared with those for 50 consecutive unselected patients who underwent open repair. The open surgical operations were performed by the Rives and Stoppa technique using prosthetic mesh, whereas the laparoscopic repairs were performed using the intraperitoneal onlay mesh (IPOM) repair technique in all cases. Results The study group consisted of 100 patients (82 women and 18 men) with a mean age of 55.25 years (range, 30–83 years). The patients in the two groups were comparable at baseline in terms of sex, presenting complaints, and comorbid conditions. The patients in laparoscopic group had larger defects (93.96 vs 55.88 cm²; p = 0.0023). The mean follow-up time was 20.8 months (95% confidence interval [CI], 18.5640–23.0227 months). The mean surgery durations were 90.6 min for the laparoscopic repair and 93.3 min for the open repair (p = 0.769, nonsignificant difference). The mean postoperative stay was shorter for the laparoscopic group than for the open hernia group (2.7 vs 4.7 days; p = 0.044). The pain scores were similar in the two groups at 24 and 48 h, but significantly less at 72 h in the laparoscopic group (mean visual analog scale score, 2.9412 vs 4.1702; p = 0.001). There were fewer complications (24%) and recurrences (2%) among the patients who underwent laparoscopic repair than among those who had open repair (30% and 10%, respectively). Conclusions The findings demonstrate that laparoscopic ventral hernia repair in our experience was safe and resulted in shorter operative time, fewer complications, shorter hospital stays, and less recurrence. Hence, it should be considered as the procedure of choice for ventral hernia repair.     

Inguinal hernia repair: results using an open preperitoneal approach

Background: Laparoscopic surgical approaches to the repair of inguinal hernias have shown the advantages of placing mesh in the preperitoneal space. Despite those advantages, laparoscopic hernia repairs have been associated with increased cost, longer operating times, and advanced laparoscopic skills. An open preperitoneal approach has the benefit of mesh in the preperitoneal position without the disadvantages of a laparoscopic procedure.Methods: We present our experience with the use of an open preperitoneal mesh repair (KugelMesh, Bard, Inc.). The study was conducted in a prospective fashion from January 1998 through October 2001. 1072 hernias were repaired in two community hospitals by three general surgeons. Patients with recurrent hernias were excluded if the initial repair was from a preperitoneal approach. Operative time, cost, post-operative pain, and complications were analyzed.Results: Recurrences occurred in five patients (0.47%) during a mean follow-up time of 23 months (range: 2–47). The average operating time was 32.4 min (range: 16–62). Post-operative narcotic pain medication usage averaged 5.8 pills (range: 0–26) per repair. Average surgical charges were less for the open preperitoneal approach ($2253) than for laparoscopic repairs ($4826).Conclusions: The open preperitoneal hernia repair using the Kugel mesh offers many advantages. It is inexpensive, has a low recurrence rate, and allows the surgeon to cover all potential defects with one piece of mesh. Postoperative recovery is short and postoperative pain is minimal.     

A self-adhering mesh for inguinal hernia repair: preliminary results of a prospective,multicenter study

Background  

Prosthetic reinforcement is the gold standard treatment for inguinal hernia and reduces the risk of recurrence. Yet up to one-third of patients complain of post-surgical pain due to irritation and inflammation caused by the mesh and the fixation materials. Of these patients, 3–4% will experience severe and disabling chronic pain. We performed a prospective multicenter clinical study of a self-adhering prosthesis, consisting of a lightweight polypropylene mesh (40 g/m2) coated on each side with synthetic glue, to evaluate early postoperative complications and patient outcomes.     

Longterm results of a prospective study of 225 femoral hernia repairs: indications for tissue and mesh repair

BACKGROUND: Femoral hernias are uncommon, and there are relatively few clinical studies of longterm outcomes after repair. Although the McVay repair has been classically described, the infrainguinal plug technique has gained popularity in recent years. Evidence supporting these repairs is sparse. STUDY DESIGN: A prospective study of elective femoral hernia repairs was done at the Shouldice Hospital from June 1999 until June 2003. The tissue-based complete groin repair (CGR) and a preperitoneal mesh repair were performed for specific indications. Patients were followed annually for 5 years to examine for recurrences and complications. RESULTS: Two hundred fifty-six patients were enrolled, with 225 completing 5 years of followup. Median age was 55 years, and hernias on the right side were more common (63.1%). Concurrent inguinal hernias were found in 115 patients (51%), and 41 (18.2%) had a previous inguinal hernia repair. A complete groin repair was performed in 120 patients and a preperitoneal mesh repair in 78. The remaining had an infrainguinal mesh repair. The overall recurrence rate was 3.1%, with a median time to recurrence of 12 months. There was no significant difference between mesh and suture repairs. Chronic postoperative pain was experienced by 20 patients (8.9%). CONCLUSIONS: Femoral hernias can be repaired electively with a tissue-based or a preperitoneal mesh technique, with durable longterm results. Mesh repair is indicated for recurrent femoral hernias, inguinofemoral hernias, prevascular hernias, association with concurrent direct hernias, and, if tension is anticipated, with complete groin repair. Infrainguinal mesh repair is used only when there has been a successful previous inguinal hernia repair.     

Inguinal hernia repair protects testicular function: a prospective study of open and laparoscopic herniorraphy

BACKGROUND: Despite the frequency of open and laparoscopic herniorraphy the effect of the hernia and subsequent repair on testicular function is unknown. Our objective was to determine if there is an association between inguinal hernia and hernia repair on testicular function. STUDY DESIGN: Thirty-seven men aged 18 to 70 years were enrolled in a prospective internally controlled cohort study. They underwent Doppler ultrasonography and serum testicular hormone analysis pre- and post- either open Lichtenstein's repair or laparoscopic totally extraperitoneal hernioplasty. These surrogates of testicular function were measured up to 6 months postrepair. RESULTS: Thirty-seven consecutive patients underwent either Lichtenstein (n = 17) or totally extraperitoneal hernioplasty (n = 20) hernia repair as per surgeon preference. Preoperatively there was a significant elevation in the sonographic resistive index (RI) in the affected (hernia) side compared with the normal side (0.601, 0.569; p < 0.001). This elevation in RI was reversed posthernia repair at a median followup of 6.1 months. Inguinal hernia or repair did not affect testicular volume. The choice of either Lichtenstein or totally extraperitoneal hernioplasty hernia did not significantly alter the testicular function. CONCLUSIONS: Patients with inguinal hernia have an elevated testicular vascular resistance, which is reversed after repair. The choice of laparoscopic or open herniorraphy did not affect reversal of this surrogate of testicular function.     

Unilateral Lichtenstein tension-free mesh hernia repair and testicular perfusion: a prospective control study

Purpose

Compare testicular perfusion between the herniated and the healthy side pre- and post-surgery.

Materials and methods

Our study was done on patients with unilateral inguinal hernia. A Doppler ultrasound study was performed in the healthy and herniated side before surgery and 3 months after it.

Results

31 patients were included, 74.2% on the right and 25.8% on the left side. When comparing the pre-surgical values of testicular resistance index from the healthy side with those on the herniated side, there was a significant difference at the spermatic cord levels (0.73 ± 0.11 and 0.81 ± 0.13, p = 0.018) and the extra-testicular level (0.66 ± 0.92 and 0.74 ± 0.10, p = 0.032), but a significant difference was not present at the intra-testicular level (0.62 ± 0.07 and 0.65 ± 0.08). Three months after the surgery, there were no statistically significant differences at any of the levels studied.

Conclusion

There are no intra-testicular perfusion differences caused by the presence of hernia, nor during post-surgery.

     

Three-year results from a preclinical implantation study of a long-term resorbable surgical mesh with time-dependent mechanical characteristics

Purpose  

The purpose of this study was to evaluate the biocompatibility, local tissue effects and performance of a synthetic long-term resorbable test mesh (TIGR^? Matrix Surgical Mesh) compared to a non-resorbable polypropylene control mesh following implantation in a sheep model.     

Cost analysis of incisional hernia repair with synthetic mesh and biological mesh: an Italian study

Repair of an incisional hernia (IH) generates costs on several levels and domains of society. The aim of this study was to make a complete cost analysis of incisional hernia repair (IHR) with synthetic and biological mesh and to compare it with financial reimbursement. Patients were grouped into three levels to determine the complexity of their care, and hence, the costs involved. Group 1 included patients without comorbidities, who underwent a “standard” incisional hernia repair (SIHR), with synthetic mesh. Group 2 included patients with comorbidities, who underwent the same surgical procedure. Group 3 included all patients who underwent a “complex” IHR (CIHR) with biological mesh. Total costs were divided into direct (including preoperative and operative phases) and indirect costs (medications and working days loss). Reimbursement was calculated according to Diagnosis-Related Group (DRG). From 2012 to 2014, 76 patients underwent prosthetic IHR: group 1 (35 pts); group 2 (30 pts); and group 3 (11 pts). The direct costs of preoperative and operative phases for groups 1 and 2 were €5544.25 and €5020.65, respectively, and €16,397.17 in group 3. The total reimbursement in the three groups was €68,292.37 for group 1, €80,014.14 for group 2, and €72,173.79 for group 3, with a total loss of €124,658.43, €69,675.36, and €100,620.04, respectively. All DRGs underestimate the costs related to IHR and CIHR, thus resulting in an important economic loss for the hospital. The cost analysis shows that patient-related risk factors do not alter the overall costs. To provide a correct “cost-based” reimbursement, different DRGs should be created for different types of hernias and prostheses.     

Prevention of parastomal hernia using preperitoneal mesh: a prospective observational study

OBJECTIVE: Parastomal hernia is a common complication after stoma formation. The objective of the study was to see whether placing prophylactic preperitoneal mesh could reduce the incidence of parastomal hernia. METHOD: Patients having elective bowel surgery requiring permanent stoma were included in this study. The time required for mesh insertion, day of stoma function, and early complications were recorded. Follow up was at 6 weeks, 3-monthly for the first year and at 6-monthly intervals thereafter. RESULTS: Eighteen patients fulfilled the inclusion criteria and were followed up for 6-28 months (mean 16.05). The time taken for mesh placement was 12-22 min (mean 14). One patient had to have revision surgery on day 1 for stomal necrosis - the mesh was left in situ in that instance. This patient developed superficial laparotomy wound infection. During the follow up, no patients developed parastomal hernia, stomal prolapse, stenosis, retraction, fistula or obstruction. CONCLUSION: The early results, in this group of patients, show that prophylactic polypropylene mesh insertion at the time of permanent stoma formation is encouraging and long-term results are awaited.     

Laparoscopic repair of recurrent groin hernia: results of a prospective study

Background  Recurrences continue to be seen after repair of inguinal hernias. The repair of these recurrent hernias is a more complex and demanding procedure, with a high re-recurrence rate. Definite advantage has been demonstrated with endoscopic repair of these hernias. Methods  The results for this prospective study from January 2003 to December 2006 were evaluated after laparoscopic repair of 65 recurrent hernias in 61 patients. The patients were followed up for 1 year. Longer follow-up evaluation was performed for the patients who underwent surgery in the initial 3 years. Results  In this study, 37 recurrent hernias were managed using the transabdominal preperitoneal technique (TAPP) technique and 28 using the totally extraperitoneal (TEP) technique. There was no conversion and no cases of postoperative wound infection. Of the 12 metachronous hernias repaired simultaneously, 3 were occult. Seroma developed in five patients. At a follow-up assessment after 1 year, one patient had groin pain, and there was one re-recurrence. A longer follow-up period with a mean of 35.11 months failed to show any new re-recurrence. Conclusions  Laparoscopic repair of recurrent inguinal hernia is safe and effective. The morbidity and recurrence rates for the procedure are as low as for laparoscopic repair of primary hernias. Laparoscopic repair should be the gold standard for these hernias.     

Efficiency and safety of mesh fixation in laparoscopic inguinal hernia repair using n-butyl cyanoacrylate: long-term biocompatibility in over 1,300 mesh fixations

Introduction  

In adult patients, most inguinal hernias are treated by implanting a prosthetic mesh. To prevent mesh dislocation and thus recurrence, different types of fixation have been proposed. In contrast to penetrating fixation known to cause acute chronic pain, adhesive fixation is becoming increasingly popular as it reduces markedly the risk of injury and chronic pain. Apart from the biological sealants (e.g., fibrin glue), surgical adhesives include a group of synthetic glues and genetically engineered protein glues. For example, cyanoacrylate is used in various medical and veterinary indications due to its fast action, excellent bonding strength and low price.