One-year outcome after open inguinal hernia repair with self-fixated mesh: a randomized controlled trial.

PURPOSE: The aim of this study was to analyze pain after surgery with the use of self-fixated meshes, which are commonly used as an alternative for sutured mesh in open inguinal hernia repair. METHODS: This prospective randomized clinical trial was conducted from November 2018 to March 2021, with a follow-up duration of 12 months. Male patients, aged 18-85, and suitable for day case surgery, were included. The patients received the self-adhesive Adhesix™ mesh or the self-gripping Progrip™ mesh in open inguinal hernia surgery. The primary outcome was the number of additional follow-up visits due to post-operative pain. Secondary outcomes included intensity of pain, quality of life measures, and complications. RESULTS: Two hundred seventy patients were included in this trial, 132 with Adhesix™ (A group), and 138 with Progrip™ (P-group). All patients' medical records were reviewed 12 months after surgery, and 207 patients (76.2%) completed 12-month follow-up. The number of patients needing additional follow-up visits 3-12 months after surgery were comparable (A group 3/3.0%, P-group 6/5.6%). The numeric rating scale was low at 12 months after surgery (at rest A 0.21, P 0.34, at exercise A 0.78, P 0.90). The incidence of chronic pain, that is moderate or severe pain during exercise, was 5 patients (5.2%) with Adhesix™ and 8 patients (7.4%) with Progrip™ (P = 0.333). Two hernia recurrences (1.0%) were established, one in each group. CONCLUSION: At 1 year after hernia surgery, the use of self-gripping and self-adhesive meshes lead to successful pain reduction and quality of life improvement. CLINICALTRIALS: com NCT03734224.

AbsorbaTack™ vs. ProTack™ vs. sutures: a biomechanical analysis of cervical fixation methods for laparoscopic apical fixations in the porcine model.

PURPOSE: Treatment of pelvic organ prolapse (POP) often requires the use of synthetic mesh. In case of a novel and standardized bilateral apical fixation, both uterosacral ligaments are replaced by polyvinylidene-fluoride (PVDF) tapes. One of the main problems remains the fixation method, which should be stable, but also simple and quick to use. The current study evaluated biomechanical differences between the cervical tape fixation with sutures (group 1), non-absorbable tacks (group 2) and absorbable tacks (group 3) in an in vitro porcine model. METHODS: A total of 28 trials, conducted in three groups, were performed on porcine, fresh cadaver uteri. All trials were performed until mesh, tissue or fixation device failure occurred. Primary endpoints were the biomechanical properties maximum load (N), displacement at failure (mm) and stiffness (N/mm). The failure mode was a secondary endpoint. RESULTS: There was a significant difference between all three groups concerning the maximum load. Group 1 (sutures) supported a maximum load of 64 ± 15 N, group 2 (non-absorbable tacks) yielded 41 ± 10 N and group 3 (absorbable tacks) achieved 15 ± 8 N. The most common failure mode was a mesh failure for group 1 and 2 and a fixation device failure for group 3. CONCLUSION: The PVDF-tape fixation with sutures supports 1.5 times the load that is supported by non-absorbable tacks and 4.2 times the load that is supported by absorbable tacks. Nevertheless, there was also a stable fixation through tacks. Sutures are the significantly stronger and cheaper fixation device but may prolong the surgical time in contrast to the use of tacks.

Mesh fixation to fascia during incisional hernia repair results in increased prevalence of pain at long-term follow up: a multicenter propensity score matched prospective observational study.

BACKGROUND: Patient-reported outcomes such as postoperative pain are critical for the evaluation of outcomes after incisional hernia repair. The aim of this study is to determine the long-term impact of mesh fixation on postoperative pain in patients operated by open and laparoscopic technique. METHODS: A multicenter prospective observational cohort study was conducted from September 2011 until March 2016 in nine hospitals across Switzerland. Patients undergoing elective incisional hernia repair were included in this study and stratified by either laparoscopic or open surgical technique. Propensity score matching was applied to balance the differences in baseline characteristics between the treatment groups. Clinical follow-up was conducted 3, 12 and 36 months postoperatively to detect hernia recurrence, postoperative pain and complications. RESULTS: Three-hundred-sixty-one patients were included into the study. No significant differences in hernia recurrence and pain at 3, 12 and 36 months postoperatively were observed when comparing the laparoscopic with the open treatment group. Mesh fixation by sutures to fascia versus other mesh fixation led to significantly more pain at 36 months postoperatively (32.8% vs 15.7%, p = 0.025). CONCLUSIONS: At long-term follow-up, no difference in pain was identified between open and laparoscopic incisional hernia repair. Mesh fixation by sutures to fascia was identified to be associated with increased pain 36 months after surgery. Omitting mesh fixation by sutures to the fascia may reduce long-term postoperative pain after hernia repair.

Three-point mesh fixation in robot-assisted transabdominal preperitoneal (R-TAPP) repair of 208 inguinal hernias: preliminary results of a single-center consecutive series.

PURPOSE: The aim of this study was to assess the efficacy of our mesh fixation technique in robot-assisted transabdominal preperitoneal inguinal hernia repair (R-TAPP). The primary outcome was the recurrence rate. Secondary outcomes were postoperative pain, chronic pain, and return to normal activities. METHODS: Between January 2018 and December 2019, we performed 208 consecutive R-TAPP in 161 patients and the mesh was fixed by three intracorporeal stiches using a Polyglactin 910 (Vicryl®) 3-0 suture. Patients were followed up at 10 and 30 days after surgery with a clinical evaluation for detection of early complications, postoperative pain, need for analgesics, return to normal activities, and satisfaction rate. Patients were further followed up at study conclusion in February 2021 for recurrence and chronic pain detection. RESULTS: Painkillers were stopped by 57% of the patients after the first postoperative day and by 96% after 1 week. Chronic pain (> 3 months after surgery) was observed in three patients (1.8%) and only one of them was treated with percutaneous ilioinguinal-iliohypogastric nerve infiltration. After a mean follow-up of 24.0 ± 6.7 months, only 1 recurrence (0.48%) was clinically detected and confirmed by a CT-scan. CONCLUSIONS: The 3-point mesh fixation technique is feasible during robot-assisted TAPP repair for inguinal hernia and seems to be a viable alternative to other fixation methods. Further long-term controlled investigations are needed to understand if this technique is effective in influencing recurrence and chronic pain rates.

Cost-effectiveness analysis of mesh fixation techniques for laparoscopic and open inguinal hernia surgeries.

PURPOSE: This study reports economic evaluation of mesh fixation in open and laparoscopic hernia repair from a prospective real-world cohort study, using cost-effectiveness analysis (CEA) and cost-utility analysis (CUA). METHODS: A prospective real-world cohort study was conducted in two university-based hospitals in Thailand from November 2018 to 2019. Patient data on hernia features, operative approaches, clinical outcomes, associated cost data, and quality of life were collected. Models were used to determine each group's treatment effect, potential outcome means, and average treatment effects. An incremental cost-effectiveness ratio was used to evaluate the incremental risk of hernia recurrences. RESULTS: The 261 patients in this study were divided into six groups: laparoscopic with tack (LT, n = 47), glue (LG, n = 26), and self-gripping mesh (LSG, n = 30), and open with suture (OS, n = 117), glue (OG, n = 18), and self-gripping mesh (OSG, n = 23). Hernia recurrence was most common in LSG. The mean utility score was highest in OG and OSG (both 0.99). Treatment costs were generally higher for laparoscopic than open procedures. The cost-effectiveness plane for utility and hernia recurrence identified LSG as least cost effective. Cost-effectiveness acceptability curves identified OG as having the highest probability of being cost effective at willingness to pay levels between $0 and $3,300, followed by OSG. CONCLUSION: Given the similarity of hernia recurrence among all major procedures, the cost of surgery may impact the decision. According to our findings, open hernia repair with adhesive or self-gripping mesh appears most cost-effective.

Laparoscopic ventral rectopexy plus sacral colpopexy: continuous locked suture for mesh fixation. A randomized clinical trial.

PURPOSE: Laparoscopic ventral rectopexy (LVR) plus sacral colpopexy (LSC) is a high-complexity surgical procedure. The aim of the present study was to evaluate a new approach to rectal-mesh fixation during LVR with continuous locked suture. METHODS: This is a prospective randomized double-blinded clinical trial enrolling 80 patients with severe POP and obstructed defecation syndrome (ODS) from November 2016 to January 2021. Patients underwent a "two-meshes" LSC plus LVR and were randomized, regarding rectal mesh fixation, in Group A (extracorporeal interrupted 0 delayed absorbable sutures) and Group B ("U-shaped" running locked 0 delayed absorbable suture). Our primary endpoints were the operative times (OT); the secondary endpoints were the incidence of anatomical failures, vaginal mesh erosions and surgical complications. RESULTS: A total of 75 patients completed the study. Baseline characteristics were similar between the groups. Overall OT (156 vs 138 min; p < 0.05; treatment reduction of 11.5%) and LVR mesh fixation time (29 vs 16 min; p < 0.05; treatment reduction of 44%), resulted in significantly lower in Group B. No differences were found in terms of anatomic failure, vaginal mesh erosion or intra- or post-operative complications. PGI-I, FSDS and Wexner questionnaires resulted significantly improved after surgery, without statistical differences between the studied surgical procedures. CONCLUSION: Laparoscopic continuous locked 0 absorbable suture for LVR mesh fixation guaranteed a faster and effective alternative to multiple interrupted sutures. The significant OT reduction linked to this technique should be considered even more helpful when performing a highly complex surgery such as LVR. CLINICAL TRIAL REGISTRATION: NCT05254860 (13/02/2017).

Dual Tack Mesh Fixation System on a Cadaveric Porcine Model-Creation of a Mesh Fixation System for Hernia Treatment and Prevention.

BACKGROUND: Onlay mesh repair (OMR) has proven to be a widely used, simple, and effective technique for treatment and prevention of hernia occurrence. Despite established benefits, there is still a lack of widespread adoption. In this study, we present the Dual Tacker Device (DTD), an enabling technology that directly addresses the limitations to the adoption of OMR, saving surgical time and effort and making OMR more reproducible across a wide range of patients. METHODS: The DTD mesh fixation system is a semiautomated, hand-held, disposable, multipoint onlay mechanical mesh fixation system that is able to rapidly and uniformly tension and fixate mesh for both hernia treatment and prevention. A cadaveric porcine model was used as a pilot test conducted during a 2 day session to assess the usability of the device and to show that the DTD provided equivalent or superior biomechanical support compared with the standard of care (hand-sewn, OptiFix). RESULTS: Our study included 37 cadaveric porcine incisional closure abdominal wall models. These were divided into four groups: DTD-mediated OMR (n = 14), hand-sewn OMR (n = 7), OptiFix OMR (n = 9), and suture-only repair (no mesh) (n = 7). Eight surgical residents performed device-mediated and hand-sewn OMR. Average time to completion was fastest in the DTD cohort (45.6s) with a statistically significant difference compared with the hand-sewn cohort (343.1s, P < 0.01). No difference in tensile strength was noted between DTD (195.32N), hand-sewn (200.48N), and OptiFix (163.23N). Discreet hand movements were smallest in the DTD (29N) and significant (P < 0.01) when compared with hand-sewn (202N) and OptiFix (35N). CONCLUSIONS: The use of the DTD is not only feasible, but demonstrated improvement in time to completion and economy of movement over current standard of care. While more testing is needed and planned, compared with conventional approaches, the DTD represents a robust proof of principle with promising implications for clinical feasibility and adoptability.

Biomechanical Parameters of Mesh Reinforcement and Analysis of a Novel Device for Incisional Hernia Prevention.

BACKGROUND: Prophylactic mesh augmentation (PMA) is an effective technique utilized to reduce the risk of incisional hernia. This study analyzes the biomechanical characteristics of a mesh-reinforced closure and evaluates a novel prophylactic mesh implantation device (SafeClose Roller System; SRS). MATERIALS AND METHODS: A total of eight senior-level general surgery trainees (≥4 years of training) from the University of Pennsylvania Health System participated in the study. Biomechanical strength, mesh stiffness, mesh uniformity, and time efficiency for fixation were compared among hand-sewn mesh fixation, SRS mesh fixation and a no-mesh fixation control. Porcine abdominal wall specimens served as simulated laparotomy models. RESULTS: Biomechanical load strength was significantly higher for mesh reinforced repairs (P = 0.009). The SRS resulted in a stronger biomechanical force than hand-sewn mesh (21.2 N stronger, P = 0.317), with more uniform mesh placement (P < 0.01), faster time of fixation (P < 0.001) and with less discrete hand-movements (P < 0.001). CONCLUSIONS: Mesh reinforcement for incisional reinforcement has a significant impact on the strength of the closure. The utilization of a mesh-application system has the potential to amplify the advantages of mesh reinforcement by providing efficiency and consistency to fixation methods, with similar biomechanical strength to hand-sewn mesh. Additional in vivo analysis and randomized controlled trials are needed to further assess clinical efficacy.

Assessment of ideal ratio of mesh area to number of fixation tacks in laparoscopic ventral and incisional IPOM Plus hernia repair.

BACKGROUND: To clarify the optimum mesh-tack ratio MTR (mesh area in cm2 divided by the number of fixation tacks) in laparoscopic ventral and incisional hernia repair, we compared IPOM Plus procedures with more intensive mesh fixation to those with standard mesh fixation. METHODS: In a retrospective cohort study, 84 patients (mean hernia width 6.6 ± 4.4 cm) intraoperatively received an intensive mesh fixation I-IPOM Plus with MTR ≤ 4:1 (e.g. ,150 cm2 mesh fixed by 50 tacks) and 74 patients (mean hernia width 6.7 ± 3.4 cm) received a standard mesh fixation S-IPOM Plus with MTR > 4:1 (e.g., 150 cm2 mesh fixed by 30 tacks) at a community hospital between 2014 and 2017. Outcomes in recurrence rates, immediate and chronic postoperative pain, as well as long-term functionality of the abdominal wall were then evaluated. RESULTS: After a mean follow-up time of 34 months, a 2.3% recurrence rate in I-IPOM Plus patients and a 13.5% recurrence rate in S-IPOM Plus patients were recorded (p = 0.018). The recurrence was associated with large hernia > 10 cm (OR 3.7, 95% CI 1.3-5.4) and MTR > 5 (OR 2.4, 95% CI 1.1-3.8) in the multivariate analysis. There was a positive correlation between immediate postoperative pain intensity measured on day 7 and number of fixation tacks placed (I-IPOM Plus: mean 4.5 ± 2.5 VAS versus S-IPOM Plus: mean 2.7 ± 2.0 VAS, p = 0.001). However, there were no outcome differences in terms of length of immediate postoperative pain experience, sick leave duration, chronic pain rate and long-term abdominal wall functionality between these two groups. CONCLUSION: For ventral and incisional hernia patients with multiple recurrence risk factors, a mesh-tack ratio MTR ≤ 4:1 should be applied in laparoscopic IPOM Plus procedures.

A comparative follow up study of transabdominal preperitoneal mesh repair in inguinal hernias with or without mesh fixation.

OBJECTIVE: To compare the recurrence rate and chronic pain in hernia patients undergoing laparoscopic or robotic transabdominal preperitoneal fixation with and without mesh. METHODS: The prospective comparative study was conducted at Surgical Units 4 and 5 of the Civil Hospital, Karachi, from August 1, 2017, to July 1, 2018, and comprised hernia patients undergoing laparoscopic or robotic transabdominal preperitoneal fixation who were randomised into fixation Group A and non-fixation Group B. Postoperative visual analogue scale score was calculated at the time of discharge. At 1-year follow-up, recurrence rate and chronic pain were assessed. Data was analysed using SPSS 23. RESULTS: Of the 98 patients, there were 49(50%) in each of the two groups. Of the total, there were 97(99%) males. The overall mean age was 44.52±14.51 years. The differences in visual analogue scale scores at the time of discharge and the mean discharge from the hospital in terms of days were statistically significant (p<0.005). At 1-year follow-up, there was recurrence in 1(1.02%) case and that was in Group A (p>0.05). Chronic pain between the groups was not significant (p>0.05). CONCLUSION: There was no significant difference in terms of recurrence and chronic pain between mesh and non-mesh fixation.

A comprehensive study comparing tack and glue mesh fixation in laparoscopic total extraperitoneal repair for adult groin hernias.

BACKGROUND: Glue mesh fixation is thought to cause less pain compared to tack mesh fixation during laparoscopic total extraperitoneal inguinal hernia repair (TEP). However, the clinical benefits of glue mesh fixation are still controversial. This study aimed to evaluate the acute pain, chronic pain, and recurrence rate between these two fixation methods. METHODS: After reviewing all patients in our prospective hernia repair database from February 2008 to December 2017, we identified 583 patients who underwent TEP with tack mesh fixation and 70 patients with glue fixation by a single surgeon. Acute post-operative pain and activity level were evaluated using a Visual Analog Score (VAS) and the modified Medical Outcome Study (MOS) score. The primary endpoint was chronic pain 6 months after TEP. The secondary endpoints were acute pain, activity level, complications, and recurrence. RESULTS: After adjustment for potential confounding factors, the glue mesh fixation had significant lower VAS at 2 h post operation during rest and coughing and on the first day after surgery during coughing (p = 0.005, p < 0.001, and p = 0.011). The modified MOS on the first day was higher in the glue group (p < 0.001). There were no reduced risk of chronic pain or increased risk of recurrence for the glue group compared to the tack group [Odds ratio (OR) = 0.237, p = 0.169; OR = 2.498, p = 0.299]. In the sub-group analysis for recurrent hernia repair, glue fixation is associated with better modified MOS (p = 0.031) on first day and lower VAS on the operative day and first day at rest (p = 0.003 and p = 0.024) after surgery. CONCLUSIONS: Glue fixation method was superior to tack fixation method in acute post-operative pain and early post-operative activity level after laparoscopic TEP repair. However, both fixation methods had similar incidence of chronic pain-, recurrence-, and procedure-related complications after laparoscopic TEP repair.

Strength comparison of different methods of closing the anterior abdominal wall defect (experimental study).

OBJECTIVE: The aim of the study is to compare the mesh implantation and the strength of the mesh fixation to the anterior abdominal wall by modelling the intraperitoneal onlay mesh repair (IPOM) with and without aponeurotic defect closure. PATIENTS AND METHODS: Materials and methods: The experimental animals were randomly divided into 2 groups of 6 rabbits. In experimental group IPOM was modelled without hernia defect closure, in control group - with its suturing. The macroscopic assessment of the severity of adhesions, histological examination of the removed "anterior abdominal wall - mesh" complex and strength of the mesh fixation to the anterior abdominal wall were performed on the 90th day. RESULTS: Results: In both groups, the displacement or complete separation of the mesh from the parietal peritoneum was not observed. The extent of adhesion formation in the abdominal cavity and strength of the mesh fixation are comparable in both groups (p > 0.05). In the experimental group, the mesh was surrounded by scar tissue, mesothelioma lining was not traced. There were also moderate signs of inflammation, which were not seen in the control group. CONCLUSION: Conclusions: The strength of the mesh fixation to the parietal peritoneum and its implantation into the anterior abdominal wall is comparable with or without aponeurotic defect closure during the experimental modelling of IPOM.

Seroma following transabdominal preperitoneal patch plasty (TAPP): incidence, risk factors, and preventive measures.

BACKGROUND: The reported range of seroma formation in the literature after TEP repair is between 0.5 and 12.2% and for TAPP between 3.0 and 8.0%. Significant clinical factors associated with seroma formation include old age, a large hernia defect, an extension of the hernia sac into the scrotum, as well as the presence of a residual indirect sac. Seroma formation is a frequent complication of laparoendoscopic mesh repair of moderate to large-size direct (medial) inguinal hernia defects. This present analysis of data from the Herniamed Hernia Registry now explores the influencing factors for seroma formation in male patients after TAPP repair of primary unilateral inguinal hernia. METHODS: In total, 20,004 male patients with TAPP repair of primary unilateral inguinal hernia were included in uni- and multivariable analysis. RESULTS: Univariable analysis revealed the highly significant impact of the fixation technique on the seroma rate (non-fixation 0.7% vs. tacks 2.1% vs. glue 3.9%; p < 0.001). Multivariable analysis showed that glue compared to tacks (OR 2.077 [1.650; 2.613]; p < 0.001) and non-fixation (OR 5.448 [4.056; 7.317]; p < 0.001) led to an increased seroma rate. A large hernia defect (III vs. I: OR 2.868 [1.815; 4.531]; p < 0.001; II vs. I: OR 2.157 [1.410; 3.300]; p < 0.001) presented a significantly higher risk of seroma formation. Likewise, medial compared to lateral inguinal hernias had a higher seroma rate (OR 1.272 [1.020; 1.585]; p = 0.032). CONCLUSIONS: Mesh fixation with tacks or glue, a larger hernia defect, and medial defect localization present a higher risk for seroma development in TAPP inguinal hernia repair.

A word of caution: never use tacks for mesh fixation to the diaphragm!

BACKGROUND: The mesh fixation technique used in repair of hiatal hernias and subxiphoid ventral and incisional hernias must meet strenuous requirements. In the literature, there are reports of life-threatening complications with cardiac tamponade and a high mortality rate on using tacks. The continuing practice of tack deployment for mesh fixation to the diaphragm and esophageal hiatus should be critically reviewed. METHODS: In a systematic search of the available literature in May 2017, 23 cases of severe penetrating cardiac complications were identified. The authors became aware of two other cases in which they acted as medical experts. Furthermore, the instructions for use issued by the manufacturers of the tacks were reviewed with regard to their deployment in the diaphragm. RESULTS: Twenty-three of 25 cases (92%) with severe cardiac injuries and subsequent cardiac tamponade were triggered by the use of tacks in the diaphragm. In six cases (24%), these related to ventral and incisional hernias with extension to the subxiphoid area, and in 19 cases (76%) to mesh-augmented hiatoplasty. Twelve of 25 (48%) patients died as a result of pericardial and/or heart muscle injury with cardiac tamponade despite heart surgery intervention. In the tack manufacturers' instructions for use, their deployment in the diaphragm, in particular in the vicinity of the heart, is contraindicated. Likewise, the existing guidelines urgently advise against the use of tacks in the diaphragm, recommending instead alternative fixation techniques. CONCLUSIONS: Tacks should not be used for mesh fixation in the diaphragm above the costal arch.

Comparison of mesh fixation devices for laparoscopic ventral hernia repair: an experimental study on human anatomic specimens.

BACKGROUND: As there is a lack of clarity in terms of the tensile strength of mesh fixation for laparoscopic ventral hernia repair (LVHR), our aim was to investigate the immediate tensile strength of currently available mesh fixation devices on human anatomic specimens. METHODS: Sixteen recently deceased body donators (mean body mass index of 24.4 kg/m2) were used to test the immediate tensile strength (Newton) of 11 different LVHR mesh fixation devices. RESULTS: Each of the 11 different laparoscopic fixation devices was tested 44 times. Non-articulating tackers provided higher fixation resistance to tensile stress in comparison to articulating tackers (5.1-mm ReliaTack™: 16.9 ± 8.7 N vs. 12.2 ± 5.6 N, p = 0.013; 7-mm ReliaTack™: 19.8 ± 9.4 N vs. 15.0 ± 7.0 N, p = 0.007). Absorbable tacks with a greater length, i.e. ≥6 mm (7-mm ReliaTack™, 6-mm SorbaFix™ and 7.2-mm SecureStrap™) had significantly higher fixation tensile strength than tacks with a shorter length, i.e. < 6 mm (5.1-mm ReliaTack™ and 5.1-mm AbsorbaTack™) (p < 0.001). Furthermore, transfascial sutures (PDS 2-0 sutures 26.3 ± 5.6 N) provided superior fixation tensile strength than 5.1-mm AbsorbaTack™ (13.6 ± 7.3 N) and cyanoacrylate glues such as LiquiBand FIX8™ (3.5 ± 2.4 N) (p < 0.001, respectively). There was a significant deterioration in fixation capacity in obese body donators with a body mass index > 30 kg/m2 (13.8 ± 8.0 vs. 17.9 ± 9.7 N, p = 0.044). CONCLUSIONS: Although articulating laparoscopic tackers improve accessibility and facilitate the utilization of tacks within the fixation weak spot adjacent to the trocar placement, an articulating shaft that is not ergonomic to use may limit mechanisms of force transmission. For mesh fixation in LVHR, transfascial sutures and tacks with a longer length provide better immediate fixation tensile strength results.

Comparison of strength of sacrocolpopexy mesh attachment using barbed and nonbarbed sutures.

INTRODUCTION AND HYPOTHESIS: We aimed to assess the pull-out strength of barbed and nonbarbed sutures used in sacrocolpopexy mesh fixation. We hypothesized there are no differences in the force needed to dislodge mesh from tissue using barbed and nonbarbed sutures of similar size. METHODS: Using the rectus fascia of three unembalmed cadavers, a 6 × 3 cm strip of polypropylene mesh was anchored to the fascia with sutures. The barbed sutures investigated were 2-0 V-Loc 180 (nine trials) and 3-0 bidirectional Quill™ SRS PDO (five trials). The nonbarbed sutures included 2-0 PDS (nine trials), CV-2 GORE-TEX (nine trials) and 2-0 Prolene (nine trials). The free-end of the mesh was anchored to a pulley system fixed to a tensiometer to measure the peak force applied at the moment of mesh dislodgement (termed the pull-out force). The pull-out force was recorded. Continuous variables are presented as medians and interquartile ranges (IQR). Analysis of variance was used to compare the forces across the suture types. RESULTS: The highest pull-out force observed was with GORE-TEX (median 65.14 N, IQR 53.37-68.77 N) followed by Prolene (median 58.98 N, IQR 54.64-62.59 N), V-Loc (median 55.23 N, IQR 51.60-58.57 N), PDS (53.96 N, IQR 51.60-57.88 N), and Quill (44.44 N, IQR 17.27-47.38 N). All 2-0 and CV-2 caliber sutures had greater pull-out forces than 3-0 Quill sutures (p < 0.01). No significant differences in pull-out forces were observed between 2-0 and CV-2 caliber sutures (p > 0.05). In 35 of the 41 trials (85%), the mesh sheared from the tissue. CONCLUSION: CV-2 ad 2-0 barbed and nonbarbed sutures had similar pull-out forces in an assessment of mesh fixation strength.

Laparoscopic sacral colpopexy and a new approach to mesh fixation: a randomized clinical trial.

PURPOSE: Laparoscopic sacral colpopexy (LSC) plus supracervical hysterectomy (LSH) for pelvic organ prolapse (POP) is a high-complexity surgical procedure. The aim of the present study was to evaluate a new approach to vaginal-mesh fixation during LSC with continuous locked suture. METHODS: This is a prospective randomized double-blinded clinical trial enrolling 90 patients with severe POP from January 2016 to April 2017. Patients underwent LSH plus a "two-meshes" LSC and were randomized, regarding mesh fixation, in Group 1 (extracorporeal interrupted 3-0 delayed absorbable sutures) and Group 2 (running locked 3-0 delayed absorbable suture). Our primary endpoints were the operative times and the secondary endpoints the incidence of intra- or post-operative complications. RESULTS: A total of 42 patients for group completed the study. Baseline characteristics were similar between the groups. Overall mesh fixation time (24 vs. 39 min; p < 0.01), and operative time (121 vs. 138 min; p < 0.05) resulted significantly lower in Group 2. No differences were found in terms of anatomic failure, vaginal mesh erosion or intra- or post-operative complications. CONCLUSIONS: Laparoscopic continuous locked 3-0 absorbable suture for anterior and posterior mesh fixation during LSC guaranteed a faster and effective alternative to multiple interrupted sutures. The significant operative time reduction linked to this technique should be considered even more helpful when performing a highly complex surgery such as LSC.

Sutures versus new cyanoacrylates in prosthetic abdominal wall repair: a preclinical long-term study.

BACKGROUND: As an alternative to sutures, meshes used for hernia repair can be fixed using cyanoacrylate-based adhesives. Attempts to improve these adhesives include alkyl-chain lengthening to reduce their toxicity. This preclinical study compares the long-term behavior of cyanoacrylates of different chain lengths already used in hernia repair and new ones for this application. MATERIALS AND METHODS: Partial abdominal wall defects were repaired using a Surgipro mesh in 18 New Zealand White rabbits, and groups were established according to the mesh fixation method: sutures (control), Glubran 2 (n-butyl), Ifabond (n-hexyl), and the new adhesives SafetySeal (n-butyl), and Evobond (n-octyl). Six months after surgery, recovered implants were examined to assess adhesive degradation, host tissue reaction, and biomechanical strength. RESULTS: All the cyanoacrylate groups showed good host tissue incorporation in the meshes. Macrophage responses to Glubran and Ifabond were quantitatively greater compared with sutures. Cell damage caused by the adhesives was similar, and only Glubran induced significantly more damage than sutures. Significantly lower collagen 1/3 messenger RNA expression was induced by Ifabond than the remaining fixation materials. No differences were observed in collagen expression except slightly reduced collagen I deposition in Glubran/Ifabond and collagen III deposition in the suture group. Mechanical strengths failed to vary between the suture and cyanoacrylate groups. CONCLUSIONS: All cyanoacrylates showed good long-term behavior and tolerance irrespective of their long or intermediate chain length. Cyanoacrylate residues persisted at 6 mo, indicating their incomplete degradation. Biomechanical strengths were similar both for the adhesives and sutures.

Behavior of a new long-chain cyanoacrylate tissue adhesive used for mesh fixation in hernia repair.

BACKGROUND: Synthetic tissue adhesives (TA) are sometimes used in hernia repair surgery. This study compares the use of a new, noncommercial, long-chain cyanoacrylate (n-octyl) TA and Ifabond for mesh fixation. MATERIALS AND METHODS: In two implant models in the rabbit, expanded polytetrafluorethylene meshes were fixed to the parietal peritoneum using a TA or tacks (intraperitoneal model), or polypropylene meshes used to repair partial abdominal wall defects were fixed with a TA or sutures (extraperitoneal model). Animals were euthanized 14 or 90 d postsurgery and implant specimens were processed for microscopy (labeling of macrophages and apoptotic cells), peritoneal fluid and biomechanical strength testing. Interleukin 6 (IL-6) and tumor necrosis factor α (TNF-α) were determinated in peritoneal fluid. RESULTS: Mesothelial cell deposition on the intraperitoneal implants fixed using the new TA and Ifabond was adequate and similar IL-6 and TNF-α levels were detected in these implants. Intraperitoneal meshes fixed with tacks showed IL-6 overexpression. Three months after surgery, macrophage and apoptotic cell rates were higher for the intraperitoneal implants fixed with Ifabond versus the new TA or tacks. In the extraperitoneal model, reduced macrophage and cell damage responses were observed in the meshes fixed with sutures versus both TA. Tensile strengths were greater for the tacks versus TA in the intraperitoneal implants and similar for the sutures and TA in the extraperitoneal implants (90 d). CONCLUSIONS: Both TA showed a good cell response in both models. Their use in an intraperitoneal location resulted in reduced tensile strength compared with the tacks. However, strengths were comparable when extraperitoneal implants were fixed with these adhesives or sutures.

Short-term strength of non-penetrating mesh fixation: LifeMesh™, Tisseel™, and ProGrip™.

BACKGROUND: Non-penetrating mesh fixation is becoming widely accepted even though little is known about the short-term fixation strength of these techniques. Although clinical outcomes are the ultimate measure of effectiveness, ex vivo biomechanical evaluation provides insights about the load-carrying capacity of the mesh-tissue complex in vivo. As such, the purpose of this study was to compare the short-term fixation strength of three unique non-penetrating methods of fixation: LifeMesh™, ProGrip™, and Tisseel™. Among these, LifeMesh™ is a novel technology where large-pore, mid-weight polypropylene mesh is embedded in a dry matrix of porcine gelatin and microbial transglutaminase enzyme, providing self-fixation without the need for a separate adhesive application. METHODS: Seven mongrel swine underwent implantation of two 4 × 7 cm pieces of either LifeMesh™, ProGrip™, or polypropylene mesh fixated with 2 mL of Tisseel™; 10 min after application, the samples were excised with the abdominal wall and stored for immediate biomechanical testing. The samples underwent lap shear testing to determine the short-term fixation strength of these three technologies. RESULTS: ProGrip™ demonstrated mean fixation strength of 1.3 N/cm (±STE 0.2). Mean fixation for mesh fixated with Tisseel™ was 2.6 N/cm (±STE 0.5). LifeMesh™ samples had mean fixation strength of 8.0 N/cm (±STE 2.1). Analysis of variance testing showed that interfacial strength of LifeMesh™ was significantly greater than that of either ProGrip™ or Tisseel™. ProGrip™ and Tisseel™ were not significantly different from each other (p = 0.06). CONCLUSIONS: Short-term strength of mesh fixation is an undescribed factor in hernia repair, but could have significant implications for early recurrence and mesh contraction. While further investigation is needed to define adequate interfacial strength, this comparison of non-penetrating mesh fixation methods shows that the novel LifeMesh™ technology exhibits greater strength than other non-penetrating fixation techniques.