The impact of atraumatic fibrin sealant vs. staple mesh fixation in TAPP hernia repair on chronic pain and quality of life: results of a randomized controlled study.
ABSTRACT Mesh reinforcement has become the standard of care in the open and laparoscopic repair of inguinal hernia. Chronic pain after inguinal hernia repair is often due to nerve injury by penetrating mesh fixation devices such as staples (ST), tacks, or sutures. In several studies on hernioplasty, atraumatic mesh fixation with fibrin sealant (FS) proved to be efficient in terms of fixation strength and elasticity. Unfortunately, most of these studies did not provide a standardized follow-up and assessment of the development of chronic pain (CP) and the quality of life (QoL). Therefore, a randomized controlled trial comparing CP and QoL after FS fixation of mesh with ST in transabdominal preperitoneal hernioplasty (TAPP) was performed at our department. The primary end point of our study was to assess the patient outcome by using a visual analog scale (VAS) and the short form 36 (SF-36). The evaluation of recurrence rates was the secondary aim.
According to the randomization, a macroporous mesh (TiMESH(®)) was fixed in group A (44 patients with 54 inguinal hernias) with FS (TISSEEL) or in group B (45 patients with 56 inguinal hernias) with ST (EMS(®) Stapler). The observation period was 1 year with regular clinical check ups and assessment of VAS and SF-36.
Patient characteristics expressed by BMI, ASA scores, and Schumpelick hernia classification were similar in both treatment groups. In each group there was one recurrence within 8 (FS) and 9 months (ST) postsurgery. The mean preoperative pain values scored by VAS were 1.7 (range = 0-7.5) in the FS group and 2.2 (range = 0-6) in the ST group. Postoperative mean VAS scores measured at 1 year postsurgery were 0.4 (range = 0-3) in the FS group and 0.9 (range = 0-7.5) in the ST group. One year postsurgery there was no significant difference between the two groups with respect to the parameter pain in the SF-36 and VAS.
Fibrin sealant fixation leads to a low rate of hernia recurrence and avoids tissue trauma. ST provide similar results in the hand of the expert but bear inherent risks of complications due to tissue perforation.
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ABSTRACT: Anchoring the mesh in laparoscopic totally extraperitoneal groin hernia repair (TEP) with human fibrin glue has theoretical advantages. However, these have been supported and reported previously only in animal studies. Before the initiation of large patient trials, the authors wanted to confirm the feasibility, assess the costs, and rule out any flagrant short- and long-term adverse effects of fibrin glue usage in a small series of patients. Nine consecutive TEP repairs with fibrin glue mesh fixation were performed. The perioperative and postoperative outcomes at 1, 16, and 40 months were compared with those for a control group of 96 stapled repairs. Gluing was easy and is less expensive than stapling. No fibrin glue-related adverse effects were found. The overall outcome was similar to that for stapled repairs, with no indication that the glued repairs were inferior. Fibrin glue seems to be a reasonable, feasible, and maybe even competitive alternative to the standard tissue-penetrating mesh fixation. The results of this study justify launching larger trials.Surgical Endoscopy 04/2006; 20(3):462-7. · 3.43 Impact Factor
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ABSTRACT: 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.Annals of Surgery 12/2005; 242(5):670-5. · 6.33 Impact Factor
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ABSTRACT: 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.Hernia 05/2007; 11(2):139-45. · 1.69 Impact Factor