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.
- SourceAvailable from: Jan F Kukleta
Article: DOI 10.1007/s00464-014-3917-8SurgEndosc. 11/2014;
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ABSTRACT: Evidence is needed to justify whether investment in an internationally agreed core outcome set for inguinal hernia surgery is needed. This study aimed to assess outcome reporting from randomised controlled trials (RCTs) and meta-analyses in inguinal hernia surgery.Hernia 08/2014; · 2.09 Impact Factor
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ABSTRACT: 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. 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. 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. 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.Frontiers in surgery. 01/2014; 1:45.