Randomized, controlled, blinded trial of Tissucol/Tisseel for mesh fixation in patients undergoing Lichtenstein technique for primary inguinal hernia repair: rationale and study design of the TIMELI trial

Campanelli, G.; Champault, G; Pascual, María Sancho; Hoeferlin, A.; Kingsnorth, Andrew; Rosenberg, Jacob; Miserez, Marc

doi:10.1007/s10029-007-0315-3

Cited by 36 publications

(39 citation statements)

References 20 publications

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“…The application of autologous P-RFS was feasible in all procedures. The mean volume of sealant we applied was comparable to previously reported volumes of normal fibrin sealants [4,5] . An absorbable stay suture was used twice after hernia sac reduction.…”

Section: Discussionsupporting

confidence: 71%

“…Nowadays, most of the commonly used sealants contain human or bovine components. Small trials using these sealants have shown promising results and were the reason for a large international randomized trial [4,5,16,17] . The incidence of pathogen transmission with these glues is very low.…”

Section: Discussionmentioning

confidence: 99%

“…These benefits have been investigated in a large multicenter trial [5] . Albeit at a very low frequency, human and bovine components of currently available fibrin sealants could contain blood-borne pathogens.…”

Section: Introductionmentioning

confidence: 99%

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Mesh Fixation with Autologous Platelet-Rich Fibrin Sealant in Inguinal Hernia Repair

Hingh

Nienhuijs²,

Overdevest³

et al. 2009

Eur Surg Res

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Background: Chronic pain is the main complication following inguinal hernia repair. A possible explanatory factor is the suture fixation of the mesh. Glue fixation might overcome this problem. Albeit at a very low frequency, human and bovine components of fibrin sealants currently available could contain blood-borne pathogens. Autologous platelet-rich fibrin sealant (P-RFS) eliminates this risk and has additional advantages such as hemostatic and antibacterial effects. Therefore, its feasibility was assessed in inguinal hernia repair, with a focus on pain. Methods: In 22 patients with primary inguinal hernia, the mesh was fixated with P-RFS. Data included operative variables, complications, pain scores and neurological examinations. Long-term follow-up was 22.2 months (SD 2.2) postoperatively. Results: After 2 weeks, visual analogue scale and disability pain scores were lower than they were preoperatively. Complications at 3 months were 1 recurrence, 1 chronic pain and 6 sensory disturbances. At the last clinical evaluation, the recurrence was planned for repair due to discomfort. No chronic pain, sensory disorders or discomfort was reported at long-term follow-up. Conclusion: Mesh fixation with autologous P-RFS is feasible. If there is a preference for autologous material, P-RFS is indicated. If glue fixation becomes standard, further randomized studies are warranted for this alternative.

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Section: Discussionsupporting

confidence: 71%

Section: Discussionmentioning

confidence: 99%

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Mesh Fixation with Autologous Platelet-Rich Fibrin Sealant in Inguinal Hernia Repair

Hingh

Nienhuijs²,

Overdevest³

et al. 2009

Eur Surg Res

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“…Several studies in various hernia repairs both open and laparoscopic using fibrin glue have shown promising results. 8,9 This is further authenticated by our study.…”

Section: Mechanism Of Actionsupporting

confidence: 71%

A prospective study of laparoscopic repair of inguinal hernia by intraperitoneal onlay mesh technique using fibrin glue

2016

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“…Generally, sutures are generally used to secure the prosthetic mesh; however, that may lead to chronic pain and other problems such as numbness or groin discomfort, presumably through tension or nerve compression [5]. Some studies showed that chronic pain was influenced by the type of the mesh implanted and its fixation [22,23]. For these reasons, some surgeons searched for a new type of atraumatic methods of fixation.…”

Section: Discussionmentioning

confidence: 99%

A Meta-Analysis Examining the Use of Fibrin Glue Mesh Fixation versus Suture Mesh Fixation in Open Inguinal Hernia Repair

Liu

Zheng

et al. 2014

Dig Surg

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Background: The aim of this study was to systematically analyze the randomized trials comparing fibrin glue mesh fixation with suture mesh fixation in open inguinal hernia repair. Methods: Information was collected from a literature search using PubMed, Springer, Cochrane Library database and reference lists. The methodological quality of included publications was evaluated. Statistical analysis was performed using Review Manager Version 5.2.5 software. Results: Nine articles were identified for inclusion: four randomized controlled trials (RCTs) and five prospective observational clinical studies. All the trials were considered to be of fair quality. The results showed that there was a lower incidence of chronic pain (RR 0.42, 95% CI 0.22-0.79, I² 11%; p < 0.01), and hematoma/seroma (RR 0.43, 95% CI 0.21-0.87, I² 0%; p < 0.05) in the fibrin glue mesh fixation group. However, the results of meta-analysis revealed that the incidence of recurrence or urinary problems between the two procedures were similar. Conclusions: During the 6-15 months follow-up, fibrin glue mesh fixation is a feasible alternative for mesh fixation with sutures in open inguinal hernia repair. However, the poor quality of the included trials limits the evidence; rigorously designed trials are warranted to confirm this conclusion.

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Randomized, controlled, blinded trial of Tissucol/Tisseel for mesh fixation in patients undergoing Lichtenstein technique for primary inguinal hernia repair: rationale and study design of the TIMELI trial

Abstract: TIMELI is a major international trial that will provide important information on the efficacy and safety of Tissucol, compared with sutures, for mesh fixation in patients undergoing Lichtenstein technique for primary inguinal hernia repair.

Cited by 36 publications

References 20 publications

Mesh Fixation with Autologous Platelet-Rich Fibrin Sealant in Inguinal Hernia Repair

Mesh Fixation with Autologous Platelet-Rich Fibrin Sealant in Inguinal Hernia Repair

A prospective study of laparoscopic repair of inguinal hernia by intraperitoneal onlay mesh technique using fibrin glue

A Meta-Analysis Examining the Use of Fibrin Glue Mesh Fixation versus Suture Mesh Fixation in Open Inguinal Hernia Repair

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