Lower reoperation rates with the use of fibrin sealant versus tacks for mesh fixation

Background

Groin hernia repair may be associated with long-term complications such as chronic pain, believed to result from damage to regional nerves by tissue penetrating mesh fixation. Studies have shown that mesh fixation with fibrin sealant reduces the risk of these long-term complications, but data on recurrence and reoperation rates after the use of fibrin sealant compared with tacks are not available. This study aimed to determine whether fibrin sealant is a safe and feasible alternative to tacks with regard to reoperation rates after laparoscopic groin hernia repair.

Methods

The current study compared reoperation rates after laparoscopic groin hernia repair between fibrin sealant and tacks used for mesh fixation. The study used data collected prospectively from The National Danish Hernia Database and analyzed 8,314 laparoscopic groin hernia repairs for reoperation rates. Mesh fixation was performed with fibrin sealant (n = 784) or tacks (n = 7,530).

Results

The findings showed a significantly lower reoperation rate for the fibrin sealant than for the tacks (0.89 vs 2.94 %, p = 0.031). The median follow-up period was 17 months (range, 0–44 months) for the fibrin sealant group and 21 months (range, 0–44 months) for the tacks group.

Conclusions

Fibrin sealant was superior to tacks for mesh fixation in laparoscopic groin hernia repair with regard to reoperation rates. The study could not differentiate between different hernia defect sizes, and future studies should therefore explore whether the superior effect of fibrin sealant applies for all hernia types and sizes.     

Staple versus fibrin glue fixation in laparoscopic total extraperitoneal repair of inguinal hernia: a systematic review and meta-analysis

Background

Fixation of mesh is typically performed to minimize risk of recurrence in laparoscopic inguinal hernia repair. Mesh fixation with staples has been implicated as a cause of chronic inguinal pain. Our study aim is to compare mesh fixation using a fibrin sealant versus staple fixation in laparoscopic inguinal hernia and compare outcomes for hernia recurrence and chronic inguinal pain.

Methods and procedures

PubMed was searched through December 2010 by use of specific search terms. Inclusion criteria were laparoscopic total extraperitoneal repair inguinal hernia repair, and comparison of both mesh fibrin glue fixation and mesh staple fixation. Primary outcomes were inguinal hernia recurrence and chronic inguinal pain. Secondary outcomes were operative time, seroma formation, hospital stay, and time to return to normal activity. Pooled odds ratios (OR) were calculated assuming random-effects models.

Results

Four studies were included in the review. A total of 662 repairs were included, of which 394 were mesh fixed by staples or tacks, versus 268 with mesh fixed by fibrin glue. There was no difference in inguinal hernia recurrence with fixation of mesh by staples/tacks versus fibrin glue [OR 2.13; 95% confidence interval (CI) 0.60–7.63]. Chronic inguinal pain (at 3 months) incidence was significantly higher with staple/tack fixation (OR 3.25; 95% CI 1.62–6.49). There was no significant difference in operative time, seroma formation, hospital stay, or time to return to normal activities.

Conclusions

The meta-analysis does not show an advantage of staple fixation of mesh over fibrin glue fixation in laparoscopic total extraperitoneal inguinal hernia repair. Because fibrin glue mesh fixation with laparoscopic inguinal hernia repair achieves similar hernia recurrence rates compared with staple/tack fixation, but decreased incidence of chronic inguinal pain, it may be the preferred technique.

     

Mesh fixation with fibrin sealant during endoscopic totally extraperitoneal inguinal hernia approach: a review of 640 repairs

Purpose

Endoscopic repair of inguinal hernia can decrease the incidence of chronic groin pain. Staple mesh fixation is the surgical technique preferentially used but may also cause residual pain. Although a substantial number of specialists advocate no mesh fixations, concerns are that this could lead to an increase in recurrence rates. This study aimed to assess the safety and the effectiveness of fibrin sealant, as an alternative technique to staple mesh fixation after totally extraperitoneal (TEP) inguinal hernia repair.

Methods

A total of 472 patients underwent elective TEP inguinal hernia repair between February 2005 and July 2011. Mesh fixation was achieved using fibrin sealant. Patients were reviewed postoperatively at Week 2, Week 6, and Month 6. Patient satisfaction was assessed in a subgroup of 116 patients using a comprehensive scoring system designed for hernia repairs, and pain was assessed using a standard Visual Analog pain Scale.

Results

No conversion to open surgery was observed. There were two cases of major morbidities and no mortality. Three months after surgery, only three patients (0.6 %) experienced chronic groin or testicular discomfort. At Week 6, 98.9 % of the patients were either satisfied or very satisfied with their outcome, and 96.8 % denied any residual pain. Finally, only six hernia recurrences (0.9 %) were reported, of which five occurred during the first months of the study.

Conclusions

Fibrin sealant is safe and reliable for mesh fixation of inguinal hernia during TEP repair with a very high satisfaction index and limited risk of developing chronic pain.     

Fibrin sealant in inguinal hernioplasty: an observational multicentre study in 1,201 patients

Purpose

A prospective, multicentre, observational study was undertaken to assess Tisseel^® fibrin sealant for atraumatic mesh fixation in inguinal hernia repair throughout France.

Methods

Surgeons recorded data on patients undergoing tension-free inguinal hernioplasty with mesh fixation with Tisseel^®, regardless of the hernioplasty technique used. Assessments were made at 2 days and 1 month after surgery. Data on local complications, operation times and ease of product use were collected.

Results

In total, 1,201 patients were recruited (90% men, mean age 57 years), among which 526 procedures were performed using open techniques and 675 using laparoscopic repairs. Local complications occurred in 4.7% of patients: 3.0% haematoma, 1.4% seroma, 0.3% recurrence. The mean visual analogue scale (VAS)-rated pain scores were 3.2 pre-operatively, 2.3 immediately after surgery and 1.8 at 1 month. Surgeons rated the product as very easy to use.

Conclusions

Tisseel^® fibrin sealant appears to be a well-tolerated and easy-to-use alternative to traditional, tissue-penetrating devices for mesh fixation in hernia repair techniques.     

Biomechanical properties of (semi-) synthetic glues for mesh fixation in endoscopic inguinal hernia repair

Purpose

In endoscopic inguinal hernia repair, the use of fibrin glues for mesh fixation instead of staples and sutures can demonstrably reduce postoperative morbidity without increasing the recurrence rate. Various fibrin glues differ in terms of their mesh fixation strength. As an alternative to fibrin glue, there is an increasing trend toward using synthetic glues for mesh fixation in both open and endoscopic inguinal hernia surgery. To date, no studies have been conducted comparing the fixation strength of (semi-) synthetic glues with that of fibrin glues. Here, using a biomechanical model, we compared the adhesive strength of two glues (BioGlue and Glubran) used in surgery with a fibrin glue.

Methods

We used light-weight polypropylene meshes (TiMesh light). In each case, the biomechanical stability of five meshes in each group was tested with 2 ml fibrin glue (Evicel), 2 ml BioGlue or 2 ml Glubran (cyanoacrylate). The defect in the muscle tissue used was 4.5 cm in diameter for a mesh size of 10 × 15 cm. Measurements were taken using a standardized stamp penetration test while aiming not to remain under a minimum fixation strength of 32 N.

Results

Using Evicel for mesh fixation, an adhesive strength of 64.3 N was achieved. This was significantly greater than that obtained in the absence of fixation (2.9 N, p < 0.001) and higher than the requisite value of 32 N. Using Glubran, it was possible once again to significantly improve the adhesive strength (105.4 N, p = 0.008). The use of BioGlue improved the adhesive strength to 131.7 N, but not significantly so compared with Glubran (p = 0.110).

Conclusions

In terms of adhesive strength, (semi-) synthetic glues can be used for mesh fixation instead of fibrin glue and even achieve significantly better adhesive strength than fibrin glue. However, further clinical studies are needed to identify the role of (semi-) synthetic glues compared with fibrin glues in endoscopic inguinal hernia surgery.     

A systematic review of randomised control trials assessing mesh fixation in open inguinal hernia repair

Purpose

The technique for fixation of mesh has been attributed to adverse patient and surgical outcomes. Although this has been the subject of vigorous debate in laparoscopic hernia repair, the several methods of fixation in open, anterior inguinal hernia repair have seldom been reviewed. The aim of this systematic review was to determine whether there is any difference in patient-based (recurrence, post-operative pain, SSI, quality of life) or surgical outcomes (operative time, length of operative stay) with different fixation methods in open anterior inguinal hernioplasty.

Methods

A literature search was performed in PubMed, EMBASE and the Cochrane Library databases. Randomised clinical trials assessing more than one method of mesh fixation (or fixation versus no fixation) of mesh in adults (>18 years) in open, anterior inguinal hernia repair, with a minimum of 6-month follow-up and including at least one of the primary outcome measures (recurrence, chronic pain, surgical site infection) were included in the review. Secondary outcomes analysed included post-operative pain (within the first week), quality of life, operative time and length of hospital stay.

Results

Twelve randomised clinical trials, which included 1,992 primary inguinal hernia repairs, were eligible for inclusion. Four studies compared n-butyl-2 cyanoacrylate (NB2C) glues to sutures, two compared self-fixing meshes to sutures, four compared fibrin sealant to sutures, one compared tacks to sutures, and one compared absorbable sutures to non-absorbable sutures. The majority of the trials were rated as low or very low-quality studies. There was no significant difference in recurrence or surgical site infection rates between fixation methods. There was significant heterogeneity in the measurement of chronic pain. Three trials reported significantly lower rates of chronic pain with fibrin sealant or glue fixation compared to sutures. A further three studies reported lower pain rates within the first week with non-suture fixation techniques compared to suture fixation. A significant reduction in operative time, ranging form 6 to 17.9 min with non-suture fixation, was reported in five of the studies. Although infrequently measured, there were no significant differences in length of hospital stay or quality of life between fixation methods.

Conclusions

There is insufficient evidence to promote fibrin sealant, self-fixing meshes or NB2C glues ahead of suture fixation. However, these products have been shown to be at least substantially equivalent, and moderate-quality RCTs have suggested that both fibrin sealant and NB2C glues may have a beneficial effect on reducing immediate post-operative pain and chronic pain in at-risk populations, such as younger active patients. It will ultimately be up to surgeons and health-care policy makers to decide whether based on the limited evidence these products represent a worthwhile cost for their patients.     

Randomized clinical trial of fibrin glue versus tacked fixation in laparoscopic groin hernia repair

Background

Preliminary studies have indicated clinical advantages of mesh fixation using fibrin glue in transabdominal preperitoneal groin hernia repair (TAPP)  compared with tack fixation. The aim of this randomized double-blinded, controlled, clinical trial is to compare fibrin glue with tacks fixation of mesh during TAPP.

Methods

One hundred and twelve men with unilateral inguinal hernia were enrolled. Primary outcome was pain during coughing on postoperative day 1. Secondary outcomes were postoperative scores of pain at rest, discomfort, and fatigue (day 1 and cumulated day 0–3), incidence of moderate/severe nausea and/or vomiting, foreign-body sensation, and recurrence after 6 months. Outcome measures were assessed by visual analogue scale (VAS, 0–100 mm), verbal rating scale (no, light, moderate or severe) and numerical rating scales (NRS, 1–10).

Results

One hundred patients were available for analysis. The fibrin group (n = 50) had significantly less pain during coughing on day 1 compared with the tacks group (n = 50) [median 23 (range 0–80) vs 35 (2–100) mm] (p = 0.020). Moreover, day 1 scores and all cumulated scores of pain during rest, discomfort, and fatigue were significantly lower in the fibrin group compared with the tacks group (all p-values ≤ 0.02). There was no significant difference in the incidence of nausea and/or vomiting (p > 0.05) or recurrence (fibrin glue n = 2, tacks n = 0, p = 0.241). Incidence of foreign-body sensation was significantly lower in the fibrin group at 1 month (p = 0.006).

Conclusions

Fibrin glue compared with tacks fixation improved the early postoperative outcome after TAPP. The trial was registered at clinicaltrials.gov NCT01000116.     

Single-port endo-laparoscopic surgery (SPES) for totally extraperitoneal inguinal hernia: a critical appraisal of the chopstick repair

Purpose

Developments in minimal access surgery brought a new concept: single-port endolaparoscopic surgery (SPES). The aim of our study is to verify the safety and feasibility of SPES TEP hernia repair and report our initial clinical outcome.

Methods

We prospectively collected data of all patients who underwent SPES TEP repair from May 2009 to December 2010. Data regarding patient demographics, type, size and location of hernia, port devices used, type of mesh and fixation, operative time, complications, length of stay and cosmetic results were collected and analyzed.

Results

A total of 47 patients (36 M, 11 F) underwent 70 SPES TEP hernia repairs; median age was 53 years (range 22–80). 60 % had indirect hernia, 27.5 % direct, 8.5 % pantaloon, 2 % femoral and 2 % recurrent hernias. Mean hernia size was 1.91 ± 0.67 cm. Port devices used include 33 Triport, 12 SILS and 2 SSL. We used anatomical mesh in 20; flat polypropylene in 10 and titanium-coated polypropylene mesh in 17 patients. Fixation of mesh was achieved in 18 patients with absorbable tacks, 8 with titanium tacks, 1 with fibrin glue, and no tack in 20 with anatomical mesh. No conversions occurred and small seroma was reported in 3 (6.3 %) patients. Mean operative time was 96.48 min (range: 50–150). Average hospital stay was 11.8 h (range: 9–26). Median follow-up was 11 months (range 6–18), and no recurrence was noted. 82.6 % patients were very satisfied, and 17.4 % were satisfied with the procedure.

Conclusion

SPES TEP repair is a safe and feasible technique with good patient satisfaction.     

Use of fibrin sealant (Tisseel/Tissucol) in hernia repair: a systematic review

Background

Abdominal wall and inguinal hernia repair are the most frequently performed surgical procedures in the United States and Europe. However, traditional methods of mesh fixation are associated with a number of problems including substantial risks of recurrence and of postoperative and chronic pain. The aim of this systematic review is to summarize the clinical safety and efficacy of Tisseel/Tissucol fibrin sealant for hernia mesh fixation.

Methods

A PubMed title/abstract search was conducted using the following terms: (fibrin glue OR fibrin sealant OR Tisseel OR Tissucol) AND hernia repair. The bibliographies of the publications identified in the search were reviewed for additional references.

Results

There were 36 Tisseel/Tissucol studies included in this review involving 5,993 patients undergoing surgery for hernia. In open repair of inguinal hernias, Tisseel compared favorably with traditional methods of mesh fixation, being associated with shorter operative times and hospital stays and a lower incidence of chronic pain. Similarly, after laparoscopic/endoscopic inguinal hernia repair, Tisseel/Tissucol was associated with less use of postoperative analgesics and less acute and chronic postoperative pain than tissue-penetrating mesh-fixation methods. Other end points of concern to surgeons and patients are the risks of inguinal hernia recurrence and of complications such as hematoma formation and intraoperative bleeding. Comparative studies show that Tisseel/Tissucol does not increase the risk of these outcomes and may, in fact, decrease the risk compared with tissue-penetrating fixation methods. When used in the repair of incisional hernias, Tisseel/Tissucol significantly decreased both postoperative morbidity and duration of hospital stay.

Conclusions

Clinical evidence published to date supports the use of Tisseel/Tissucol as an option for mesh fixation in open and laparoscopic/endoscopic repair of inguinal and incisional hernias. Guidelines of the International Endohernia Society recommend fibrin sealant mesh fixation, especially in inguinal hernia repair. Nonfixation is reserved for selected cases.     

Beneficial effects of fibrin glue (Quixil) versus Lichtenstein conventional technique in inguinal hernia repair: a randomized clinical trial

Introduction

In inguinal hernia repair, many complications are due to mesh fixation technique. Therefore, new types of atraumatic methods of fixation have been proposed. In this article, we present the results of a prospective multicentric parallel randomized controlled trial aiming to compare two mesh fixation techniques: fibrin sealant (QUIXIL^®, Omrix Biopharmaceuticals S.A., Belgium) and Lichtenstein technique.

Method

Adult patients with primary uncomplicated inguinal hernia were randomized in two groups: fibrin sealant group (FSG) and Lichtenstein group (LTG). The two groups underwent a follow-up of 15 months. Operative time is the primary outcome. Intraoperative and postoperative outcomes were analyzed. Moreover, a differential cost analysis was performed. Patients and evaluators (with exception of the surgeon who treated the patient) were blinded.

Results

A total of 102 patients, 50 in FSG and 52 in LTG, were enrolled from January 2009 to June 2010, and two patients were lost to follow-up at the twelfth month. No significant differences in baseline and clinical characteristics were observed in the two groups. Operative time was longer in LTG (median/ interquartile range: 35 min/30–42.5 min vs. 31 min/28–35 min; effect size: 0.65/95 % CI 0.50–0.91; p < 0.05). No differences in intraoperative complications were observed. No significant differences were observed in early complication rate (RR = 0.62; p > 0.05). Numbness rate was lower in the FSG at 1 week (RR = 0.43; p < 0.01) and at 1 month (RR = 0.17; p < 0.05). No significant differences were observed after 6 months. Postoperative pain was lower in the FSG at 1 week (0/0–1 vs. 1/0–2; p < 0.05) and at 1 month (0/0–0 vs. 0/0–1; p < 0.05). Pain disappeared in all patients after 6 months. Analgesic assumption rate was lower in the FSG (RR = 0.42; p < 0.05). Twenty per cent of FSG and 9.62 % of LTG patients were discharged within 12 h; 78 % of FSG and 90.38 % of LTG patients were discharged within 24 h. The only one recurrence we observed was in FSG group. About costs, although fibrin sealant needed for one mesh fixation is about 10 times more costly than the needed sutures, the total costs of the two procedures did not change significantly. This was mainly due to reduction in operative time.

Conclusions

The use of fibrin sealant determined a significant reduction in short-term numbness rate and postoperative pain. There was no relevant difference in total costs per patient between the two procedures.     

Effectiveness and safety of n-butyl-2-cyanoacrylate medical adhesive for noninvasive patch fixation in laparoscopic inguinal hernia repair

Background

Our purpose was to compare the recurrence rate and other clinical outcomes of laparoscopic (LS) transabdominal preperitoneal (TAPP) inguinal hernia repair using n-butyl-2-cyanoacrylate (NBCA) for mesh fixation with those of no mesh fixation and mesh fixation with titanium spiral tacks (ST).

Methods

The medical records of patients who received LS TAPP inguinal hernia repair between 2009 and 2012 at our institution were reviewed. Patients were included if the received LS TAPP with either no mesh fixation, mesh fixation with NBCA only, fixation with ST only, or fixation with NBCA + ST. Outcome measures were operation time, postoperative length of stay, visual analogue scale (VAS) pain score 24 h after surgery, postoperative complications, and hernia recurrence.

Results

A total of 1,027 TAPP cases were included. In 552 cases, meshes were fixed with NBCA only, in 89 cases only ST were used, in 47 cases ST and NBCA were used, and in 339 cases meshes were not fixed. The groups were comparable with respect to demographic and clinical characteristics. No surgical complications occurred in any group. VAS pain scores were significantly lower in the nonfixation and NBCA only groups (1.4 ± 0.6 and 1.3 ± 0.6, respectively) than in the ST and NBCA + ST groups (2.2 ± 0.9 and 2.2 ± 0.7, respectively; P = 0.001). The mean follow-up duration was ~19 months. At the final follow-up, no wound infections or hernia recurrences had occurred in any of the groups. No occurrence of chronic pain was noted in the nonfixation and NBCA only groups, whereas two cases (2.2%) were noted in the ST group and one case (2.1%) in the NBCA + ST group (P = 0.005).

Conclusions

The use of NBCA medical adhesive for noninvasive patch fixation in laparoscopic hernia repair (TAPP) is effective and safe.     

Influence of Type of Mesh Fixation in Endoscopic Totally Extraperitoneal Hernia Repair (TEP) on Long-term Quality of Life

Introduction

Laparoscopic total extraperitoneal mesh repair (TEP) of inguinal hernia has become well accepted with low recurrence and high patient satisfaction rates. However, inguinal pain has also been reported. Source of this pain has been suggested to be the fixation method, especially the use of tacks. Introduction of fibrin glue and absorbable tacks were suggested to lower chronic pain and inguinal discomfort rates. This study analyses the different methods of fixation.

Patients and Methods

201 patients were analysed. Primary end-points were patients’ satisfaction, health-related quality of life, and specific inguinal conditions (e.g. pulling, swelling, troubles at coughing). Secondary endpoints were duration of operation, length of hospital stay, and material costs.

Results

Fibrin glue was used in 101 patients and tacks in 100 patients, in 21 of those absorbable tacks. Patients were fully satisfied with the results in more than 90%, irrespective of the fixation method. Health-related quality of life along the SF-12^® questionnaire attested no differences. Inguinal pulling occurred significantly more often after fibrin glue (25.7 %) than after tack fixation (11 %; p = 0.026), whereas no differences in the other specific inguinal sensations occurred.

Conclusion

Mesh fixation in TEP can be performed either by tacks or by fibrin glue with similar long-term results concerning satisfaction, health-related quality of life, and pain. No advantage of fibrin glue could be found, in fact, a higher percentage of patients had inguinal pulling and burning sensations after the use of fibrin glue. The use of absorbable tacks showed no advantage.     

Internal plug mesh without fixation in laparoscopic total extraperitoneal (TEP) repair of inguinal hernias: a pilot study

Purpose

Mesh fixation is essential in laparoscopic total extraperitoneal (TEP) repair of inguinal hernia; however, fixation sometimes causes post-operative pain. This study investigated a novel method of laparoscopic TEP repair without mesh fixation.

Methods

This study reviewed data from about two-hundred and forty-one laparoscopic TEP repairs on 219 patients, which were performed between December 2004 and October 2005.

Results

There were no statistically significant differences in the recurrence rate, seroma formation, and hospital stay. However, the mean operation time was shorter in the internal plug mesh group than the fixation group (p = 0.009), and post-operative pain only occurred in 4 cases in the internal plug mesh group in comparison to 29 cases in the mesh fixation group (p = 0.014).

Conclusions

An internal plug mesh without fixation might reduce post-operative pain after laparoscopic TEP repair of an inguinal hernia. Internal plug mesh without fixation may be an alternative method in laparoscopic TEP repair, especially for those involving indirect hernias.     

Mesh size in Lichtenstein repair: a systematic review and meta-analysis to determine the importance of mesh size

Purpose

Small mesh size has been recognized as one of the factors responsible for recurrence after Lichtenstein hernia repair due to insufficient coverage or mesh shrinkage. The Lichtenstein Hernia Institute recommends a 7 × 15 cm mesh that can be trimmed up to 2 cm from the lateral side. We performed a systematic review to determine surgeons’ mesh size preference for the Lichtenstein hernia repair and made a meta-analysis to determine the effect of mesh size, mesh type, and length of follow-up time on recurrence.

Methods

Two medical databases, PubMed and ISI Web of Science, were systematically searched using the key word “Lichtenstein repair.” All full text papers were selected. Publications mentioning mesh size were brought for further analysis. A mesh surface area of 90 cm² was accepted as the threshold for defining the mesh as small or large. Also, a subgroup analysis for recurrence pooled proportion according to the mesh size, mesh type, and follow-up period was done.

Results

In total, 514 papers were obtained. There were no prospective or retrospective clinical studies comparing mesh size and clinical outcome. A total of 141 papers were duplicated in both databases. As a result, 373 papers were obtained. The full text was available in over 95 % of papers. Only 41 (11.2 %) papers discussed mesh size. In 29 studies, a mesh larger than 90 cm² was used. The most frequently preferred commercial mesh size was 7.5 × 15 cm. No papers mentioned the size of the mesh after trimming. There was no information about the relationship between mesh size and patient BMI. The pooled proportion in recurrence for small meshes was 0.0019 (95 % confidence interval: 0.007–0.0036), favoring large meshes to decrease the chance of recurrence. Recurrence becomes more marked when follow-up period is longer than 1 year (p < 0.001). Heavy meshes also decreased recurrence (p = 0.015).

Conclusion

This systematic review demonstrates that the size of the mesh used in Lichtenstein hernia repair is rarely discussed in clinical studies. Papers that discuss mesh size appear to reflect a trend to comply with the latest recommendations to use larger mesh. Standard heavy meshes decrease the recurrence in hernia repair. Even though there is no evidence, it seems that large meshes decrease recurrence rates.     

Evaluation of fibrin sealant for biologic mesh fixation at the hiatus in a porcine model

Background

The ideal method to secure biologic mesh during laparoscopic hiatal hernia repair remains uncertain. Suture or tack fixation can be technically difficult, and serious cardiovascular complications have been reported. Fibrin sealant (FS) offers a potential solution to this problem. We hypothesized that FS provides comparable mesh fixation to suture repair during laparoscopic mesh hiatoplasty.

Study design

Using a porcine model, laparoscopic hiatal hernia repair was performed with suture reapproximation of the crura and reinforcement with an acellular porcine dermal matrix. Prior to repair, animals were randomized to mesh fixation with sutures (S) or FS. After 30-day survival, an esophagram was performed, the diaphragm harvested, and mesh position, fixation, and incorporation were evaluated histologically and biomechanically using a T-peel test.

Results

Twenty (10 S and 10 FS) laparoscopic hiatal hernia repairs were performed. Total operative time was significantly less in the FS group (74.7 versus 127.0?min, p?<?0.01). There were no instances of mesh migration in any animal. Mean peel force did not differ significantly between the S and FS groups (0.21 vs. 0.18?N/mm, respectively; p?=?0.49). There was no significant difference in cellular repopularization or inflammatory changes around the mesh.

Conclusions

Fibrin sealant offers a reasonable alternative to suturing biologic mesh during laparoscopic hiatal hernia repair with equivalent mesh fixation. At 30 days it provides adhesive strength similar to suture fixation, while significantly reducing operative time.     

Lower Reoperation Rate for Recurrence after Mesh versus Sutured Elective Repair in Small Umbilical and Epigastric Hernias. A Nationwide Register Study

Background

Repair for a small (≤2 cm) umbilical and epigastric hernia is a minor surgical procedure. The most common surgical repair techniques are a sutured repair or a repair with mesh reinforcement. However, the optimal repair technique with regard to risk of reoperation for recurrence is not well documented. The aim of the present study was in a nationwide setup to investigate the reoperation rate for recurrence after small open umbilical and epigastric hernia repairs using either sutured or mesh repair.

Materials and methods

This was a prospective cohort study based on intraoperative registrations from the Danish Ventral Hernia Database (DVHD) of patients undergoing elective open mesh and sutured repair for small (≤2 cm) umbilical and epigastric hernias. Patients were included during a 4-year study period. A complete follow-up was obtained by combining intraoperative data from the DVHD with data from the Danish National Patient Register. The cumulative reoperation rates were obtained using cumulative incidence plot and compared with the log rank test.

Results and conclusions

In total, 4,786 small (≤2 cm) elective open umbilical and epigastric hernia repairs were included. Age was median 48 years (range 18–95 years). Follow-up was 21 months (range 0–47 months). The cumulated reoperation rates for recurrence were 2.2 % for mesh reinforcement and 5.6 % for sutured repair (P = 0.001). The overall cumulated reoperation rate for sutured and mesh repairs was 4.8 %. In conclusion, reoperation rate for recurrence for small umbilical and epigastric hernias was significantly lower after mesh repair compared with sutured repair. Mesh reinforcement should be routine in even small umbilical or epigastric hernias to lower the risk of reoperation for recurrence avoid recurrence.     

A comparison of a bovine albumin/glutaraldehyde glue versus fibrin sealant for hernia mesh fixation in experimental onlay and IPOM repair in rats

Background

Research in hernia repair has targeted new atraumatic mesh fixation to reduce major complications such as chronic pain and adhesion formation. The efficacy and safety of two surgical adhesives, viz. Artiss^® (FS, fibrin sealant containing 4 IU thrombin) and Bioglue^® (AGG, bovine serum albumin/glutaraldehyde glue), were evaluated in this study. Primary study endpoints were tissue integration, dislocation, and adhesion formation. Foreign-body reaction formed the secondary study endpoint.

Methods

Twenty-four polypropylene meshes (VM, Vitamesh^®) were randomized to four groups (n = 6): two groups of onlay hernia repair (two meshes per animal) with mesh fixation by FS (O-FS) or by AGG (O-AGG), and two groups of IPOM repair (one mesh per animal) with mesh fixation by four sutures and FS (I-FS) or AGG (I-AGG). Eighteen rats underwent surgery. Follow-up was 30 days. Tissue integration, dislocation, seroma formation, inflammation, adhesion formation, and foreign-body reaction were assessed.

Results

Meshes fixed with FS (O-FS, I-FS) showed good tissue integration. No dislocation, seroma formation, or macroscopic signs of inflammation were detectable. Adhesion formation of I-FS was significantly milder compared with I-AGG (P = 0.024). A moderate foreign-body reaction without active inflammation was seen histologically in O-FS and I-FS groups. Samples fixed with AGG (O-AGG, I-AGG) showed extensive scar formation. No dislocation and no seroma formation were observed. All of these samples showed moderate to severe signs of inflammation with abscess formation in the six meshes of O-AGG. Histology underlined these findings.

Conclusions

The fibrin sealant adhesive showed very good overall results of the primary and secondary outcome parameters. FS is a recommendable atraumatic fixation tool for the surgical onlay technique. AGG provides high adhesive strength, but shows low biocompatibility. Persisting active inflammation was seen in both the O-AGG and I-AGG groups, not favoring its use for these indications.     

Closing the gap: medialization of fascia with laparoscopic incisional hernia repair

Purpose

Laparoscopic incisional hernioplasty (LIH) bridges the fascial gap between the rectus muscles with a posteriorly placed mesh, and is a low recurrence alternative to other reconstructions. It is unclear if this repair optimizes the function of the abdominal wall. We hypothesize that significant medialization of the fascial edges occurs in patients who undergo LIH.

Methods

Two hundred fifty-eight patients underwent LIH by a single surgeon between 2004 and 2012. 44 of these had pre- and postoperative CT scans that illustrated the gap between the rectus muscles. All 44 patients underwent LIH with polyester composite mesh, with suture and tack fixation. The distance between the fascial edges on the pre- and postoperative CT scans was compared. Percent medialization was calculated for each defect.

Results

Average fascial separation reduction was 0.8 cm (6.56–5.76 cm, 12.2 % medialization, p < 0.0001). 36 of 44 patients demonstrated a reduction in hernia defect width (81.8 %): these defects reduced 1.09 cm (6.47–5.38 cm, 16.9 % medialization, p < 0.0001). In defects wider than 5 cm, the width reduced by 0.94 cm (8.48–7.54 cm, n = 26, 10.6 % medialization, p = 0.004). The use of meshes ≥500 cm² reduced the defect by 0.95 cm (8.42–7.47 cm, 11.23 % medialization, n = 22, p = 0.005).

Conclusions

Significant medialization of the rectus muscles is evident in most patients undergoing LIH. Although the rectus muscles are not ideally approximated, this may help improve the function of the anterior abdominal wall. Further technical refinements and material improvements may improve the reconstructive results of the LIH.     

Post-operative benefits of Tisseel®/Tissucol® for mesh fixation in patients undergoing Lichtenstein inguinal hernia repair: secondary results from the TIMELI trial

Purpose

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.

Methods

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.

Results

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.

Conclusions

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.     

Tensile strength testing for resorbable mesh fixation systems in laparoscopic ventral hernia repair

Background

In an attempt to improve patient outcome and quality of life after laparoscopic ventral hernia repair, resorbable fixation devices have been developed to allow adequate mesh fixation while minimizing accompanying side-effects as tack erosion and adhesion formation.

Materials and methods

In experimental set-up, 24 pigs were treated by laparoscopic mesh placement. Two different meshes (PP/ORC and PP/ePTFE) and four fixation devices were evaluated: a 6.4?mm poly(D,L)-lactide pushpin (tack I), a 6.8?mm poly(D,L)-lactide with blunt tip (tack II), a 4.1?mm poly(glycolide-co-L-lactide) (tack III) and one titanium tack (control tack). A first group of animals (n?=?12) was euthanized after 2?weeks survival and a second group (n?=?12) after 6?months. At euthanasia, a relaparoscopy was performed to assess adhesion formation followed by laparotomy with excision of the entire abdominal wall. Tensile strength of the individual fixation systems was tested with the use of a tensiometer by measuring the force to pull the tack out of the mesh. Additionally, the foreign body reaction to the fixation systems was evaluated histologically as was their potential degradation.

Results

At 2?weeks the tensile strength was significantly higher for the control tack (31.98?N/cm2) compared to the resorbable devices. Except for tack II, the tensile strength was higher when the devices were fixed in a PP/ePTFE mesh compared to the PP/ORC mesh. After 6?months only tack III was completely resorbed, while tack I (9.292?N/cm2) had the lowest tensile strength. At this time-point similar tensile strength was observed for both tack II (29.56?N/cm2) and the control tack (27.77?N/cm2). Adhesions seem to be more depending on the type of mesh, in favor of PP/ePTFE.

Conclusion

At long term, the 4.1?mm poly(glycolide-co-L-lactide) tack was the only tack completely resorbed while the 6.8?mm poly(D,L)-lactide tack with blunt tip reached equal strengths to the permanent tack.