Fibrin Sealant For Mesh Fixation Research Articles

Short-Term Outcomes of Fibrin Glue Versus Absorbable Tackers for Mesh Fixation in Laparoscopic TAPP Inguinal Hernia Repair: A Randomised Clinical Trial

Introduction: Hernia is defined as the protrusion of all or part of a viscus through the wall that contains it. Laparoscopic and tension-free open repairs are the two procedures that are being performed globally in inguinal hernia surgery. Aim: To compare the benefits of fibrin glue versus absorbable tackers in laparoscopic Transabdominal Preperitoneal (TAPP) inguinal hernia repair and to appraise their outcomes. Materials and Methods: A randomised clinical trial was conducted at a tertiary hospital of SRM Medical College Hospital and Research Centre, Chennai, Tamil Nadu, India for 18 months, from March 2021 to August 2022. Total of 54 patients who had laparoscopic TAAP hernia repairs were divided into two groups each with 27 participants, group A mesh fixed using fibrin glue and group B mesh fixed using absorbable tackers. All the patients were followed-up for atleast three months postsurgery. Operating time, postoperative pain and complications data were collected. The Chi-square and Unpaired t-test determined the statistical significance of the data. Results: Total of 54 patients aged 18 to 60 years were included in the study with no significant differences (p-value=0.696). The same was true for gender (11 males and 43 females), with no significant differences (p-value=0.735) in group A and group B between male and female patients. In current study, there was a statistically significant difference in pain levels between groups after 24 hours, hours (group B: 5.33±1.30 and group A: 6.56±0.51) however, after 48 hours (group B: 4.07±0.87 and group A: 4.63±0.49) and 72 hours (group B: 2.74±0.76 and group A: 2.63±0.49), there was no significant difference in the severity of the pain between the groups. At one week follow-up the level of pain score was significantly different. There was also a significant difference in haematoma between groups (p-value=0.038). In addition, there was a significant difference in return to normal activities in one week (p-value=0.033), two weeks (p-value=0.022), and four weeks between groups (p-value=0.019). Conclusion: The use of fibrin sealant for mesh fixation in TAPP surgery has superior short-term outcomes when compared to tackers in terms of postoperative pain, return to normal activities and reduced incidence of haematomas.

Outcome of the "Manchester Groin Repair" (Laparoscopic Totally Extraperitoneal Approach With Fibrin Sealant Mesh Fixation) in 434 Consecutive Inguinal Hernia Repairs.

Introduction: This study looks at the outcome of 352 patients that underwent the “Manchester groin repair” in the period from 2007 to 2016. The effect of laterality on chronic groin pain and the reduction of pain scores post-surgery are evaluated as well as the rate of hernia recurrence for the inguinal hernia repairs.Methods: The “Manchester groin repair” is a modification of a laparoscopic totally extra-peritoneal approach with fibrin sealant mesh fixation. Data were collected prospectively. In addition to demographic data and the European Hernia Society classification grading of each hernia, pain scores were assessed prior to surgery and at 4–6 weeks post-operatively using a ten-point visual analog pain scale. Data were collected on a bespoke database and differences between time-points analyzed by non-parametric Wilcoxon signed rank tests with Kruskal-Wallis rank sum test for three-group comparisons. Significance was at the P < 0.05 level. The study was undertaken as an institutional audit.Results: Three hundred and fifty two patients underwent TEP repair as per the “Manchester Groin Repair” modification during the period of interest with a median follow-up period of 109.5 (IQR 57.0–318.5) weeks. Of these 274 (77.8%) were for the repair of true hernias and 78 (22.2%) were for inguinal disruptions.All inguinal hernia repairs patients were evaluated (254 m, 20 f); median [interquartile range] age 50 (39–65) years. There were 75 right inguinal hernias (27.4%), 39 Left inguinal hernias (14.2%), and 160 bilateral inguinal hernias (58.4%), giving a total of 434 hernia repairs. During follow-up there were 6 recurrences (1.4%).Of the 274 patients evaluated, 145 (52.9%) had both pre and post-operative pain scores available. Median pre-operative pain score was 5 [IQR 4–7]. Median post-operative pain score was 1 [IQR 1–2]. This difference was significant (P < 0.001). Pre-operative pain scores were higher for those with a bilateral hernia (median 6 vs. 5 and 4, respectively; P = 0.005), but there was no difference in post-operative scores (P = 0.347). One patient (0.3%) presented with chronic groin pain (pain after 3 months).Conclusion: This study demonstrates that the “Manchester groin repair” provides an excellent repair with a low rate of recurrence and low incidence of chronic pain. Longer-term evaluation and larger patient series will add to the understanding of the role of this procedure in groin hernia repair.

Cost comparison of fibrin sealant versus tack screws for mesh fixation in laparoscopic repair of inguinal hernia

ABSTRACTObjectives: Inguinal hernias of the abdominal wall are common accounting for 75% of all hernia defects. They can be treated with laparoscopic surgery using a transabdominal preperitoneal (TAPP) approach. However, in surgery there is some contention on how to conclude the hernia repair, as there are alternatives of using fibrin sealant (FS) or tack screws for fixation of a mesh implant over the defect in the abdominal wall. In this study, we evaluate the economic consequences of using FS vs. tacks for mesh fixation in TAPP inguinal hernia repair for the UK from a hospital perspective.Methods: The model was populated with clinical inputs (theater time, hospitalization days, occurrence of seroma, and neuralgia) from a previously conducted study comparing FS and tack screws in patients who had undergone TAPP hernia repair, and cost inputs from official government sources. One-way sensitivity analyses were also conducted to evaluate key drivers of cost analyses.Results: The average cost per case treated with FS 2 mL Tisseel® and tack screws (ProTackTM) was £1,098 and £1,348, respectively, for resource expenses paid by the healthcare system. This would suggest a potential savings achieved of £249 per surgery using FS for mesh fixation. The sensitivity analysis showed that the key drivers for the cost difference were a variation in time to complete the surgery, followed by hospitalization days, and lower adverse outcomes such as seroma and neuralgia in the two cohorts.Conclusion: Using FS resulted in cost savings in hospitals based on reduced time to complete surgery, hospitalization time post-op, and lower adverse outcomes. Indirect cost savings were also found in favor of FS when comparing the two alternatives from a societal perspective, as patients were able to return to work more promptly in the FS group versus the tack screws group.

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.

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.

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.

The impact of hydrophobic hernia mesh coating by omega fatty acid on atraumatic fibrin sealant fixation.

Fibrin sealant (FS) is a safe and efficient fixation method in open intraperitoneal hernia repair. While favourable results have been achieved with hydrophilic meshes, hydrophobic (such as Omega fatty acid coated) meshes (OFM) have not been specifically assessed so far. Atrium C-qur lite(®) mesh was tested in rats in models of open onlay and intraperitoneal hernia repair. 44 meshes (2×2cm) were implanted in 30 male Sprague-Dawley rats in open (n=2 meshes per animal) and intraperitoneal technique (IPOM; n=1 mesh per animal). Animals were randomised to four groups: onlay and IPOM sutured vs. sealed. Follow-up was 6weeks, sutured groups serving as controls. Evaluation criteria were mesh dislocation, adhesions and foreign body reaction. FS provided a reliable fixation in onlay technique, whereas OFM meshes dislocated in the IPOM position when sealed only. FS mesh fixation was safe with OFM meshes in open onlay repair. Intraperitoneal placement of hydrophobic meshes requires additional fixation and cannot be achieved with FS alone.

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.

Clinical outcome and quality of life in 100 consecutive laparoscopic totally extra-peritoneal (TEP) groin hernia repairs using fibrin glue (Tisseel™): a United Kingdom experience

The use of fibrin sealant (FS) (Tisseel™) for mesh fixation in patients undergoing laparoscopic groin hernia surgery is a well-recognised technique in Europe, but no study to date has examined effect on quality of life (QoL) on patients undergoing FS mesh fixation. A prospective study was therefore conducted to examine the effects on QoL of patients undergoing laparoscopic groin hernia surgery using FS in the United Kingdom. Between March 2007 and January 2011, all patients undergoing laparoscopic total extra preperitoneal (TEP) groin hernia repair using FS were included in the study. A validated hernia questionnaire from The Royal College of Surgeons of England supplemented by the EORTC QLQ C-30 to assess the pre- and postoperative QoL, pain scores and health outcome measures was used. All the patient's demographics, duration of surgery, size of hernia, recurrence, morbidity and hospital stay were recorded. Data from 92 patients (87 males and 5 females) with a median age of 46years (range, 19-82years) was collected for the study (response rate of 92/121, 73%). A total of 58 patients (63%) had a unilateral and 34 patients (37%) a bilateral hernia repair, of which 6 (7%) were recurrent inguinal hernia. The mean operating time for a unilateral hernia was 36min (30-62), and that for a bilateral hernia was 59min (51-83). There were no conversions to open surgery out of the 92 patients included with the recorded morbidity of 7%. There were no early recurrences. Eighty-nine patients (98%) of patients were discharged in the first 24h after surgery. There was a significant statistical difference recorded in patients visual analogue pain score (VAS 0-10) before and after surgery (P<0.0001, Mann-Whitney U test). The physical, emotional, social and health components of the questionnaire were statistically significant pre- and postoperatively (P<0.001 Mann-Whitney U test). Groin hernia TEP repair with FS fixation did not have a detrimental effect on QoL and pain scores. In addition, the low early recurrence rate provided good evidence of the mesh fixation properties of FS. FS can therefore be continued to be recommended, as an alternative fixation method in laparoscopic groin hernia surgery.

Randomized, Controlled, Blinded Trial of Tisseel/Tissucol for Mesh Fixation in Patients Undergoing Lichtenstein Technique for Primary Inguinal Hernia Repair

Test the hypothesis that fibrin sealant mesh fixation can reduce the incidence of postoperative pain/numbness/groin discomfort by up to 50% compared with sutures for repair of inguinal hernias using the Lichtenstein technique. Inguinal hernia repair is the most common procedure in general surgery, thus improvements in surgical techniques, which reduce the burden of undesirable postoperative outcomes, are of clinical importance. A randomized, controlled, patient- and evaluator-blinded study (Tissucol/Tisseel for MEsh fixation in LIchtenstein hernia repair [TIMELI]; trial NCT00306839) was conducted among patients eligible for Lichtenstein repair of uncomplicated unilateral primary inguinal small-medium sized hernia. Patients were subject to mesh fixation with either fibrin sealant or sutures. Main outcome measures were visual analogue scale (VAS) assessments for "pain," "numbness," and "groin discomfort" on a scale of 0 = best and 100 = worst outcome. The primary endpoint was a composite that evaluated the prevalence of chronic disabling complications (VAS score >30 for pain/numbness/groin discomfort) at 12 months after surgery. In total, 319 patients were randomized between January 2006 and April 2007 (159 fibrin sealant, 160 sutures). At 12 months, the prevalence of 1 or more disabling complication was significantly lower in the fibrin sealant group than in the sutures group (8.1% vs 14.8%; P = 0.0344). Less pain was reported in the fibrin sealant group than in the sutures group at 1 and 6 months (P = 0.0132; P = 0.0052), as reflected by a lower proportion of patients using analgesics in the fibrin group over the study duration (65.2% vs 79.7%; P = 0.0009). Only 3 of 316 patients (0.9%) experienced recurrence. The incidences of wound-healing complications and other adverse events were comparable between groups. Fibrin sealant for mesh fixation in Lichtenstein repair of small-medium sized inguinal hernias is well tolerated and reduces the rate of pain/numbness/groin discomfort by 45% relative to sutures without increasing hernia recurrence (NCT00306839).

Guidelines for laparoscopic (TAPP) and endoscopic (TEP) treatment of inguinal hernia

We thank Christophe Berney for his interesting and very important Letter to the Editor, in which he addresses a number of aspects of the evidence-based technique of total extraperitoneal patchplasty (TEP) discussed in the ‘‘Guidelines for laparoscopic (TAPP) and endoscopic (TEP) treatment of inguinal hernia’’ [1]. The technique must once again be clarified in more precise terms. At issue is the role of fibrin sealant for mesh fixation in TEP and the implications of the role of fibrin sealant in seroma formation. Christophe Berney reports on his own experiences with fibrin sealant for mesh fixation in 650 TEP operations with low complication and recurrence rates [2]. In the subsection entitled ‘‘Should a drain be used after a TEP repair? Should seromas be aspirated?’’ [1, p. 2794], the study by Lau [3] is cited as a level 1B statement. In that prospective randomized comparative study of bilateral inguinal hernias, it was noted that the use of fibrin sealant compared to staples for mesh fixation in TEP led to a significant reduction in the need for analgesics, but it also led to a significant rise in the rate of postoperative seromas. Here it is important to focus on the definition used by Lau [3] for a postoperative seroma: ‘‘A seroma was defined as the clinical presence of a palpable fluid collection over the groin in the absence of bruising during follow-up.’’ Also noteworthy in the Lau study [3] is that the proportion of direct hernias was very high, amounting to 56.5% in the fibrin sealant group and 58.5% in the staple group. In the Lau study [3] a clinically palpable seroma with protrusion of the skin was noted in only 5.3% of cases in which staples were used and in 17.4% (p = 0.009) of cases in which fibrin sealant was used for mesh fixation. Therefore, by virtue of the Lau study [3], it must be borne in mind that mesh fixation to Cooper’s ligament with staples tends to be more suitable for prevention of a clinically palpable seroma with protrusion of the skin in the groin after a TEP operation for direct hernias. The classification system used in the Guidelines means that queries relating to both TEP and TAPP are dealt with in separate sections. Therefore, further statements and commentaries on the issues raised by Christophe Berney can be checked in Chapter 9, ‘‘Mesh fixation modalities: is there an association with acute or chronic pain?’’ and Chapter 10, ‘‘Risk factors and prevention of acute and chronic pain.’’ On p. 2822 there is a clear statement on the scientific level 1B whereby the risk of acute and chronic pain after staple mesh fixation is higher compared with fibrin fixation or nonfixation. On p. 2817 nonfixation of mesh in TEP is then elaborated on in greater detail: ‘‘In total, seven studies have compared fixation versus nonfixation in TEP, of which only two have 1 B evidence level. They did not discover any difference in the incidence of recurrence between fixated versus nonfixated mesh. In total, 12,114 hernia repairs F. Kockerling D. A. Jacob (&) Department of Surgery and Center for Minimally Invasive Surgery, Vivantes Hospital, Neue Bergstr. 6, 13585 Berlin, Germany e-mail: dietmar.jacob@vivantes.de

Fibrin Sealant for Mesh Fixation in Endoscopic Inguinal Hernia Repair: Is There Enough Evidence for Its Routine Use?

Fibrin sealing has recently evolved as a new technique for mesh fixation in endoscopic inguinal hernia repair. A comprehensive Medline search was carried out evaluating fibrin sealant for mesh fixation, and finally 12 studies were included (3 randomized trials, 3 nonrandomized trials, and 6 case series). The trials were assessed for operative time, seroma formation, recovery time, recurrence rate, and acute and chronic pain.There was a trend toward decreased operative times for fibrin sealing compared with mechanical stapling; however, the results for seroma formation remained contradictory. The most important finding was the reduced postoperative pain. Recovery times were lower after fibrin sealing and the recurrence rates showed no differences.Fibrin sealing for mesh fixation in the endoscopic inguinal hernia surgery is a promising alternative to mechanical stapling, which can be safely applied. As the overall quality of published data remains poor, further well-designed studies are needed until fibrin sealing can replace mechanical stapling as a new standard for mesh fixation.

Evaluation of intraperitoneal placement of absorbable and nonabsorbable barrier coated mesh secured with fibrin sealant in a New Zealand white rabbit model

This study aimed to evaluate the acute and chronic fixation strength of fibrin sealant (FS) as an alternative method of fixation for laparoscopic ventral hernia repair (LVHR). Representative mesh types for LVHR included one nonabsorbable barrier mesh (Composix) and three absorbable barrier meshes (Sepramesh, Proceed, and Parietex composite). Macroporous polypropylene mesh (Prolite Ultra) served as the control mesh. Three methods of fixation were used, namely, 0-polypropylene suture+FS (ARTISS 4 IU), FS alone (ARTISS), and tacks alone, to secure 3×4-cm pieces of mesh (10 of each combination) to the peritoneal surface of New Zealand white rabbit abdominal wall. After 2 h of incubation at 37 °C, specimens underwent acute testing. Subsequently, a chronic phase was completed using the aforementioned fixation methods (10 of each combination), in which two 4×4-cm pieces of mesh were secured intraperitoneally in each of 75 New Zealand white rabbits, which survived 8 weeks until they were sacrificed. A transparent grid overlay was used to measure the mesh and adhesion area. Adhesion tenacity was characterized using the Garrard adhesion scale. In both the acute and chronic samples, a 3×3-cm area of mesh-tissue interface underwent lap shear testing at a rate of 0.42 mm/s using a tensiometer (Instron 5542). The maximum load sustained by the mesh-tissue construct was recorded as the acute fixation strength in newtons (N). Data are given as means±standard error of the mean. Statistical significance (p<0.05) was determined using a one-way analysis of variance (ANOVA) with Fisher's least significant difference (LSD) posttest or a nonparametric Kruskal-Wallis test (adhesion scores). The acute fixation strength was significantly greater for all the meshes secured with either suture+FS or tacks alone than for FS alone (p<0.001 for all comparisons). All the meshes except Proceed demonstrated greater acute fixation strength with suture+FS than with tacks alone (p≤0.016). Composix achieved greater acute fixation with suture+FS than all the other meshes (p≤0.022). Acute fixation with suture + FS was greater for Parietex Composite and ProLite Ultra than for Proceed (p≤0.015). When the animals were sacrificed, 48 of 50 meshes fixed with FS alone were insufficiently affixed to the abdominal wall, which may have resulted in hernia recurrence in a hernia model. The chronic fixation strength was greater for all the mesh types with either suture+FS or tacks only than with FS alone (p≤0.0005). The chronic fixation strength was greater with suture+FS than with tacks for Proceed and ProLite Ultra (p≤0.013). Neither mesh area nor adhesion tenacity differed significantly with any mesh/fixation method combination. In a chronic rabbit model of LVHR, fixation strength with FS alone was inadequate for selected nonabsorbable and absorbable barrier-coated meshes. The acute and chronic fixation strengths of suture+FS were equivalent or superior to the fixation strength of tacks alone. Using a combination of suture and FS for mesh fixation in LVHR may provide adequate fixation while decreasing postoperative pain due to spiral titanium tacks. In this preclinical series, mesh secured to the peritoneal surface by FS alone may have led to early recurrence.

Fibrin sealant for mesh fixation in Lichtenstein repair: biomechanical analysis of different techniques

Mesh fixation using sealants is becoming increasingly popular in hernia surgery. Fibrin sealant is an atraumatic alternative to suture or stapler fixation and is currently the most frequently used sealant. There are currently no biomechanical data available for evaluation of the quality of adhesion achieved with fibrin sealant during Lichtenstein hernia repair. Five different suture and sealant techniques were evaluated and compared during simulated Lichtenstein hernia repair in an established, standardised biomechanical model for abdominal wall hernias. Significantly greater stability was achieved with fibrin sealant fixation of meshes than with point-by-point suture fixation. Fibrin adhesion protected meshes from dislocation at least as well as suture fixation with additional running-suture closure of the hernia orifice. Fibrin mesh fixation combined with additional support from running-suture hernia closure was significantly (P < or = 0.002) superior to all other methods. On the basis of these favourable biomechanical properties, mesh fixation using fibrin sealant can be recommended for use in onlay repair of transinguinal hernias.

Fibrin Sealant Versus Mechanical Stapling for Mesh Fixation During Endoscopic Extraperitoneal Inguinal Hernioplasty

To compare the clinical outcome of simultaneous bilateral endoscopic totally extraperitoneal inguinal hernioplasty (TEP) using fibrin sealant (FS) and mechanical stapling for prosthetic mesh fixation. Similar efficacy of FS and mechanical stapling for mesh fixation has been demonstrated in a swine model, but no clinical trial has been conducted to compare the outcomes of TEP using these 2 fixation devices. FS adheres the prosthetic mesh without causing injury to the underlying structures. Whether the application of FS improves early postoperative outcomes, namely, reduction of postoperative pain and seroma formation, has not been examined. Between July 2002 and February 2004, a total of 93 patients with 186 inguinal hernias who underwent bilateral TEP were randomized to have mesh fixation by either FS (n = 46) or mechanical stapling (n = 47). The primary endpoints were severity of pain, analgesic requirement, and incidence of seroma. Secondary endpoints were length of hospital stay, number of days required to resume normal outdoor activities and work, recurrence rate, and incidence of chronic pain. The 2 groups were comparable in age, sex, and types of hernia. TEP were successfully performed in all patients. The FS group consumed significantly less analgesics compared with that of the staple group (P = 0.034). There was no significant difference in the postoperative pain score at rest and on coughing from the day of operation to postoperative day 6 between the groups. The incidence of seroma was significantly higher in the FS group (17.4%) than the staple group (5.3%) (P = 0.009). Length of hospital stay and time taken to resume normal activities and work were comparable between the 2 groups. With a median follow-up of 1.2 years, no recurrent hernia has been detected in either group, but the incidence of chronic pain in the staple group (20.0%) was higher than that of the FS group (13.2%) (P = 0.418). This randomized prospective clinical trial demonstrated a significant reduction of analgesic consumption by using FS for mesh fixation during bilateral TEP, but it was associated with an increased incidence of postoperative seroma.