Tack Group Research Articles

TACKoMesh – A randomised controlled trial comparing absorbable versus non-absorbable tack fixation in laparoscopic IPOM + repair of primary incisional hernia using post-operative pain and quality of life - Reliatack™ versus Protack™

There is a clinical need to better understand and improve post-operative pain for patients undergoing laparoscopic repair of incisional hernia. The aim of this single-centre, double-blind, randomised controlled trial was to compare post-operative pain between absorbable and non-absorbable tack fixation in patients undergoing IPOM + repair. Patients with primary incisional hernia (size 3–10 cm), were randomised to either Reliatack™ (n = 27), an articulating-arm device deploying absorbable polymer tacks, or Protack™ (n = 36), a straight-arm device deploying permanent titanium tacks. The primary outcome was reported pain on activity using a visual analogue scale at post-operative day 30. Clinical and patient-reported outcome measures (PROMs) were assessed pre-operatively (day 0), and at 1-, 6-, 30- and 365-days post-surgery. No significant differences in reported pain ‘on activity’ were found at any timepoint. Less reported pain ‘at rest’ was found on post-operative day-1 with absorbable tacks (p = 0.020). Significantly longer mesh-fixation time (p < 0.001) and the use of more knots for fascial closure (p = 0.006) and tacks for mesh-fixation (p = 0.001) were found for the absorbable tack group. There were no differences in other clinical and PROMs between groups. For the whole trial cohort (n = 63) several domains in the Short-Form-36 showed a reduction from baseline scores at day 30 that improved at day 365. At post-operative day 30, 75.0% of patients reported ‘a lot of pain’ since discharge. This study found no difference in reported pain when choosing absorbable or non-absorbable tack fixation. The utility of “early” post-operative pain assessment as a comparator following incisional hernia repair needs clarification.

The Evolutionary Origins of Extreme Halophilic Archaeal Lineages

Interest and controversy surrounding the evolutionary origins of extremely halophilic Archaea has increased in recent years, due to the discovery and characterization of the Nanohaloarchaea and the Methanonatronarchaeia. Initial attempts in explaining the evolutionary placement of the two new lineages in relation to the classical Halobacteria (also referred to as Haloarchaea) resulted in hypotheses that imply the new groups share a common ancestor with the Haloarchaea. However, more recent analyses have led to a shift: the Nanohaloarchaea have been largely accepted as being a member of the DPANN superphylum, outside of the euryarchaeota; whereas the Methanonatronarchaeia have been placed near the base of the Methanotecta (composed of the class II methanogens, the Halobacteriales, and Archaeoglobales). These opposing hypotheses have far-reaching implications on the concepts of convergent evolution (distantly related groups evolve similar strategies for survival), genome reduction, and gene transfer. In this work, we attempt to resolve these conflicts with phylogenetic and phylogenomic data. We provide a robust taxonomic sampling of Archaeal genomes that spans the Asgardarchaea, TACK Group, euryarchaeota, and the DPANN superphylum. In addition, we assembled draft genomes from seven new representatives of the Nanohaloarchaea from distinct geographic locations. Phylogenies derived from these data imply that the highly conserved ATP synthase catalytic/noncatalytic subunits of Nanohaloarchaea share a sisterhood relationship with the Haloarchaea. We also employ a novel gene family distance clustering strategy which shows this sisterhood relationship is not likely the result of a recent gene transfer. In addition, we present and evaluate data that argue for and against the monophyly of the DPANN superphylum, in particular, the inclusion of the Nanohaloarchaea in DPANN.

Mesh fixation techniques in primary ventral or incisional hernia repair.

Mesh fixation techniques in primary ventral or incisional hernia repair.

The effect of tack number and balloon trocar use on acute post-operative pain scores of patients who underwent TEP repair of inguinal hernia

Aim: As the novel technology on surgical procedures evolve, the management and amelioration strategies for postoperative pain gains importance for surgeons to improve patients’ life quality and postoperative outcomes. In this study, we aimed to compare the number of tacks placed during surgery and the use of intra-operative balloon trocars during TEP repair of inguinal hernias with respect to post-operative early pain scores.Methods: A total of 83 patients were included in this prospective cohort study, 59 being in the 0-1 tack group and 24 in the 2 tacks group. Balloon trocar was used in 32 patients. All patients underwent laparoscopic TEP inguinal hernia repair. Groups were compared with respect to pain scores on 3rd, 12th and 24th postoperative hours. Results: Pain score was better in no balloon trocar+2 tacks group when compared to balloon trocar+2 tacks and no balloon trocar+0-1 tack group at the 24th postoperative hour (P=0.02 and P=0.007, respectively), and in the balloon trocar+0-1 tack group than that of the no balloon trocar+0-1 tack group (P=0.004). There was no statistically significant difference between these four groups in terms of pain score on the 3rd and 12th hours of surgery (P=0.46 and P=0.24, respectively). Patients in the 0-1 tack group reported less pain on the 24th postoperative hour (3.1 (6.3) vs 14.1 (21.8); P=0.32).Conclusion: Using less number of tacks and avoiding using balloon trocar result in lower pain scores following laparoscopic TEP repair of inguinal hernias.

Evaluation of Chronic Groin Pain Rates After TEP Hernioplasty – A Single-Center Study

Summary Total extraperitoneal hernioplasty (TEP) has become increasingly used by surgeons. The TEP procedure is technically more challenging due to space constraints and has a higher learning curve. Chronic groin pain after inguinal hernia repair has become the dominant outcome investigated rather than recurrence. We aimed to evaluate the rate of chronic groin pain after TEP inguinal hernia repair performed at the Department of Surgical Oncology in G. Stranski University Hospital – Pleven. The procedures performed totaled 36. There was one conversion, and the patient was excluded from the study because the procedure performed was not laparoscopic. Distribution according to inguinal hernia type was: 41.7% - indirect hernia (15), 36.1% - direct hernia (13), 13.9% combined (5), and 8.3% femoral (3). Twenty-eight of the patients (80%) had preoperative pain. Two of the patients with chronic groin pain had had their meshes fixed with tacks (14.3% from the tack group with p=0.7). Our study showed that the TEP procedure is a safe, feasible operation with minimal risk for complications. Using tacks for mesh fixation is associated with higher rates of chronic groin pain, but it does not affect the recurrence rate, which correlates with the literature review data.

Massive Incisional Hernia Repair with Parietex: Monocentric Analysis on 500 Cases Treated with a Laparoscopic Approach.

The aim of this retrospective study is to demonstrate the safety and feasibility of the laparoscopic technique for treatment of massive incisional hernias (MIHs) and to compare three different fixation devices. From January 1, 2001, to December 31, 2014, we collected retrospective data from patients with large incisional hernias (IHs). Laparoscopic IH repair is performed by applying a three-dimensional polyester knit structure mesh with a resorbable collagen barrier on peritoneal side (Parietex™ Composite Mesh; Covidien, New Haven, CT). Patients were divided into three groups according to the different fixation devices. The mean follow-up was 19 (12-156) months. The mean defect size was 12.83 cm (10-26 cm) and the mean body mass index was 30.8 kg/m2 (26-39 kg/m2). The EMS stapler™ was used on 260 patients, the Protack® on 210 patients, and the AbsorbaTack™ on 30 patients. The mean operative time was 69.9 minutes (38-130 minutes). Intraoperative morbidity rate was 1.6% (8 cases). Early reoperation rate was 0.2% (1 case). The mean length of hospital stay was 2.3 days (range 2-7 days). Seromas were observed in 20 patients (4.0%) and neuralgia in 10 patients (2.0%). Recurrence was observed in 12 patients (2.4%) with the majority in the absorbable tack group (10%). There were no conversions (0%) to open technique. The laparoscopic approach seems to be safe and appropriate for treatment of MIH. The Parietex composite mesh we used guarantees excellent intraabdominal laparoscopic repair of abdominal wall defects. Absorbatack system seems to give less postoperative neuralgia, but it is related to a high recurrence rate. Protack system seems to give more postoperative neuralgia than the Endopath EMS. In our experience, the best fixation system is the latter.

Fibrin sealant for mesh fixation in laparoscopic groin hernia repair does not increase long-term recurrence.

Methods of groin hernia repair include laparoscopic techniques using tissue-penetrating mesh fixation or non-penetrating fixation. Concerns regarding hernia repair include postoperative chronic pain, sexual dysfunction, and recurrence. Earlier estimations of recurrence rates have largely been based on nationwide databases, where reoperation rates have been used as a surrogate measure for recurrence, which may underestimate the true recurrence rates. The aim of this study was to evaluate long-term recurrence in patients who had undergone transabdominal pre-peritoneal (TAPP) laparoscopic groin hernia repair using either fibrin sealant or tacks for mesh fixation. This study used data from the Danish Hernia Database to create the following cohort: All patients operated laparoscopically for primary groin hernia with a TAPP procedure using fibrin sealant for mesh fixation. These patients were matched 1:2 with patients, where the mesh was fixated using tacks. A validated questionnaire was sent to all included patients to determine recurrence, which was defined as reoperation or clinical diagnosis of recurrence by a physician. Follow-up was from index operation to either reoperation date, date of clinical recurrence diagnosis, or response date. A total of 2273 persons (n = 2340 groins) were included, of which 1535 returned the questionnaire, resulting in a response rate of 66.2% with a median follow-up time of 31 months (range 0-62). Among these, 114 (7.4%) recurrences were found, of which 30 (5.8%) were in the fibrin sealant group and 84 (8.3%) in the tacks group (p = 0.084). The Cox regression analysis found no difference in recurrence with the use of tacks compared to fibrin sealant (hazard ratio 0.8) [95% CI (0.5-1.2)]. We found no significant difference in long-term reoperation rates and clinical recurrences in patients undergoing TAPP repair with meshes fixated with fibrin sealant compared with tacks.

Mesh fixation techniques in primary ventral or incisional hernia repair

Mesh fixation techniques in primary ventral or incisional hernia repair

Tacks, staples, or suture: method of peritoneal closure in laparoscopic transabdominal preperitoneal inguinal hernia repair effects early quality of life.

TAPP inguinal hernia repair (IHR) entails the development of a peritoneal flap (PF) in order to reduce the hernia sac and create a preperitoneal space in which to place mesh. Many methods for closure of the PF exist including sutures, tacks, and staples. We hypothesized that patients who had PF closure with suture would have better short-term QOL outcomes. A prospective institutional hernia-specific database was queried for all adult, TAPP IHRs from July 2012 to August 2013. Unilateral and bilateral patients were included and each hernia was analyzed separately. The main outcome of interest was quality of life (QOL) at two- and four-week follow-up, as measured by the Carolinas Comfort Scale. There were 227 patients who underwent TAPP, with 99 bilateral and 128 unilateral IHR, for a total of 326 IHR. PF closure was performed using tacks in 45.1%, suture in 19.0%, and staples in 35.9%. Patient characteristics were statistically similar between the tack, suture, and staple group. There were 32.9% direct, 46.5% indirect, and 20.6% pantaloon hernias, which were not significantly different when compared by PF closure method. Post-operative complications and length of stay were same for the three groups. There were no hernia recurrences. Post-operative activity limitation at two weeks was significantly better in the suture group when compared to the stapled group (p = 0.005). Additionally, sutured PF closure had less early post-operative pain when compared to the tack group (p = 0.038). Following TAPP IHR, suture closure of the PF significantly improves 2-week post-operative movement limitation compared to stapled and tacked PF closure. Continued randomized studies are needed to determine the best surgical hernia repair methods for ideal post-op QOL.

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

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. 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). 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. 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.

Fibrin sealant for mesh fixation in laparoscopic umbilical hernia repair: 1-year results of a randomized controlled double-blinded study

Fibrin sealant for mesh fixation has significant positive effects on early outcome after laparoscopic ventral hernia repair (LVHR) compared with titanium tacks. Whether fibrin sealant fixation also results in better long-term outcome is unknown. We performed a randomized controlled trial including patients with umbilical hernia defects from 1.5 to 5 cm at three Danish hernia centres. We used a 12 cm circular mesh. Participants were randomized to fibrin sealant or titanium tack fixation. Patients were seen in the outpatient clinic at 1 and 12 months follow-up. Forty patients were included of whom 34 were available for intention to treat analysis after 1 year. There were no significant differences in pain, discomfort, fatigue, satisfaction or quality of life between the two groups at the 1-year follow-up. Five patients (26 %) in the fibrin sealant group and one (6 %) in the tack group were diagnosed with a recurrence at the 1-year follow-up (p = 0.182) (overall recurrence rate 17 %). Hernia defects in patients with recurrence were significantly larger than in those without recurrence (median 4.0 vs. 2.8 cm, p = 0.009). Patients with larger hernia defects and fibrin sealant mesh fixation had higher recurrence rates than expected, although the study was not powered for assessment of recurrence. There was no significant difference between groups in any parameters after the 1-year follow-up. The beneficial effects of mesh fixation with fibrin sealant on early outcome warrant further studies on optimization of the surgical technique to prevent recurrence.

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

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

Randomized clinical trial of fibrin sealant versus titanium tacks for mesh fixation in laparoscopic umbilical hernia repair

The use of tacks for mesh fixation may induce pain after surgery for ventral hernia. The aim of this study was to compare postoperative pain after laparoscopic ventral hernia repair (LVHR) with conventional mesh fixation using titanium tacks versus fibrin sealant (FS). This randomized clinical trial included patients with an umbilical hernia defect ranging from 1·5 to 5 cm at three Danish hernia centres. Participants were assigned randomly to FS or titanium tack fixation. The primary outcome was acute pain, defined as the mean pain score on days 0-2 after surgery, measured on a 0-100-mm visual analogue scale (VAS). Forty patients were included, of whom 38 were available for intention-to-treat analysis after 1 month. Patients in the FS group reported less pain than those in the tack group on days 0-2, both at rest (median 19 versus 47 mm; P = 0·025) and during activity (38 versus 60 mm; P = 0·014). The absolute difference in pain score between groups was 19 (95 per cent confidence interval 3 to 34) and 20 (4 to 35) mm at rest and during activity respectively. Patients in the FS group resumed normal daily activity earlier (after median 7 versus 18 days; P = 0·027) and reported significantly less discomfort. No recurrences were observed. Mesh fixation with FS in LVHR was associated with less acute postoperative pain, discomfort and a shorter convalescence than tack fixation. Long-term follow-up is needed to show whether the effect of FS fixation persists in terms of chronic pain and recurrence. NCT00842842 (http://www.clinicaltrials.gov).

Evaluation of absorbable and permanent mesh fixation devices: adhesion formation and mechanical strength

Laparoscopic ventral hernia repair is commonly performed with mesh prostheses; however, there is no standard for fixation devices used to secure mesh to the abdominal wall. This study is a functional comparison of novel, screw-type absorbable and permanent fixation devices with a traditional titanium fixation device. Fifteen pigs each underwent the laparoscopic placement of two 11×14-cm mesh prostheses and were randomized for mesh fixation with either titanium spiral tacks (TS), absorbable screw-type fasteners (SF), or permanent screw-type fasteners (PF) (n=10 mesh prostheses for each fixation group). Adhesions were assessed laparoscopically at 4weeks. The fixation devices were also embedded in porcine abdominal rectus muscle for ex vivo mechanical testing along with partial thickness polypropylene suture (PR) as a control group (n=40 for each group). Maximum pull-off forces were measured. All statistical tests were two-tailed, and a P-value<0.05 was considered to be significant. The mean tenacity adhesion scores were 1.40±0.52 (PF), 1.7±0.82 (SF), and 2.6±1.07 (TS). Adhesions in the PF group were significantly less tenacious compared with the TS group (P=0.01). Quantitative adhesion scores were not significantly different among groups. The maximum pull-off forces, measured in Newtons, were 28.61N±4.89N (TS), 22.71N±7.86N (SF), 16.98N±7.59N (PF), and 20.83N±6.25N (PR). The pull-off force in the TS group was higher than all of the other groups (P<0.001). The SF group also had a higher pull-off force compared with the PF group (P<0.001). The screw-type absorbable and permanent fixation devices provided adequate fixation and were associated with decreased adhesions in this porcine model.

A Biomechanical Comparison of Repair Techniques for Type II SLAP Lesions

Background Multiple options exist for repair of superior labral tears. Purpose To compare commonly used fixation techniques for superior labral tears. Study Design Biomechanical cadaveric study. Methods A comparison of the initial strengths of fixation for type II superior labral anterior posterior (SLAP) lesions was performed in three cadaveric shoulder groups, each containing seven specimens. Two groups were repaired with screw-in anchors; one group had vertical sutures, the other horizontal. Group 3 was repaired using bioabsorbable tacks. Cyclic traction was applied to the biceps tendon. Repair failure (2 mm of permanent displacement) and ultimate failure were measured. Results Specimen stiffness was similar between groups. The mean load to repair failure was 123 ± 17 N in group 1, 114 ± 11 N in group 2, and 95 ± 13 N in group 3. The mean load to ultimate failure was 163 ± 15 N, 161 ± 12 N, and 145 ± 12 N, respectively. Although the repair failure loads of groups 1 and 2 were 29% and 17%, respectively, greater than the tack group, the differences were not statistically significant (P> .05). All ultimate failures occurred at the labral-implant interface. Conclusion Initial fixation strength of tissue tack and suture anchor repairs of SLAP lesions are comparable.