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

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

doi:10.1097/sla.0b013e31824b32bf

Cited by 104 publications

(113 citation statements)

References 26 publications

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“…The discussion on identification of the ''genitofemoral nerve'' (which we entirely agree should be named ''genital branch'') is to some extent semantic as we agree that routine direct identification should not be done, but only if necessary for the herniotomy per se. This may explain our low identification rate of the genital branch (21.3 %) which, interestingly, is within the same range as reported from a recent hernia specialist publication on persistent pain problems, with an identification rate of 26.5 % [3]. Also, we agree that the use of heavy-weight mesh may have contributed to the pain problems, but when the study was conducted there was little conclusive evidence for differences between mesh type and persistent pain.…”

supporting

confidence: 70%

Intraoperative nerve identification and chronic postherniorrhaphy pain

Kehlet¹,

Bischoff²,

Aasvang³

et al. 2012

Hernia

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First of all, we thank Drs. Chen and Amid [1] for their very thoughtful comments and update on the role of intraoperative nerve identification during groin hernia repair and the risk of development of chronic pain. We agree with all their comments, except that our conclusions in the abstract does not ''conclude that nerve identification does not decrease rates of pain in routine practice'' as quoted, but rather that ''although intraoperative inguinal nerve identification should be aimed at, other factors may contribute to the risk of nerve damage and persistent pain after open groin hernia repair '' [2]. This conclusion supports the comments by Chen and Amid [1], despite that we in the present study were not able to demonstrate any influence of nerve identification on signs of nerve damage or on development of persistent pain. The discussion on identification of the ''genitofemoral nerve'' (which we entirely agree should be named ''genital branch'') is to some extent semantic as we agree that routine direct identification should not be done, but only if necessary for the herniotomy per se. This may explain our low identification rate of the genital branch (21.3 %) which, interestingly, is within the same range as reported from a recent hernia specialist publication on persistent pain problems, with an identification rate of 26.5 % [3]. Also, we agree that the use of heavy-weight mesh may have contributed to the pain problems, but when the study was conducted there was little conclusive evidence for differences between mesh type and persistent pain.In summary, the valuable comment by Drs. Chen and Amid provides a sound balance on this important (but also difficult) topic of persistent postherniorrhaphy pain compared to our rather negative findings [1]. We entirely support their conclusion that surgical technique is a crucial component to reduce this disturbing problem.

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supporting

confidence: 70%

Intraoperative nerve identification and chronic postherniorrhaphy pain

Kehlet¹,

Bischoff²,

Aasvang³

et al. 2012

Hernia

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“…A prospective randomised multicentre trial reports a significant reduction in postoperative pain at 1 and 6 months and a 45 % reduction in incidence of a composite endpoint regarding chronic disabling complications (pain/numbness/groin discomfort) at 1 year after Lichtenstein repair with fibrin glue (heavyweight) mesh fixation compared to standard suture fixation [30]. Two other RCTs comparing, respectively, cyanoacrylate glue fixation (under local anaesthesia) [31] and fibrin glue (under spinal anaesthesia) [32] with standard fixation of a large pore mesh during Lichtenstein repair showed less acute pain at 24 h and lower incidence of hematoma formation and less pain and numbness at 1 week and 1 month.…”

Section: Open Surgerymentioning

confidence: 99%

Update with level 1 studies of the European Hernia Society guidelines on the treatment of inguinal hernia in adult patients

Miserez

Peeters

Aufenacker

et al. 2014

Hernia

366

226

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Purpose: In 2009, the European Hernia Society published the EHS Guidelines for the Treatment of Inguinal Hernia in Adult Patients. The Guidelines contain recommendations for the treatment of inguinal hernia from diagnosis till aftercare. The guidelines expired January 1, 2012. To keep them updated, a revision of the guidelines was planned including new level 1 evidence. Methods: The original Oxford Centre for Evidence-Based Medicine ranking was used. All relevant level 1A and level 1B literature from May 2008 to June 2010 was searched (Medline and Cochrane) by the Working Group members. All chapters were attributed to the two responsible authors in the initial guidelines document. One new chapter on fixation techniques was added. The quality was assessed by the Working Group members during a 2-day meeting and the data were analysed, especially with respect to any change in the level and/or text of any of the conclusions or recommendations of the initial guidelines. In the end, all relevant references published until January 1, 2013 were included. The final text was approved by all Working Group members. Results: For the following topics, the conclusions and/or recommendations have been changed: indications for treatment, treatment of inguinal hernia, day surgery, antibiotic prophylaxis, training, postoperative pain control and chronic pain. The addendum contains all current level 1 conclusions, Grade A recommendations and new Grade B recommendations based on new level 1 evidence (with the changes in bold). Conclusions: Despite the fact that the Working Group responsible for it tried to represent most kinds of surgeons treating inguinal hernias, such general guidelines inevitably must be fitted to the daily practice of every individual surgeon treating his/her patients. There is no doubt that the future of guideline implementation will strongly depend on the development of easy to use decision support algorithms tailored to the individual patient and on evaluating the effect of guideline implementation on surgical outcome. At the 35th International Congress of the EHS in Gdansk, Poland (May 12-15, 2013), it was decided that the EHS, IEHS and EAES will collaborate from now on with the final goal to publish new joint guidelines, most likely in 2015

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“…Six studies reported the incidence of chronic pain after inguinal hernia repair [1,8,9,12,13,14]. Five of them reported a lower percentage of chronic pain in the fibrin group, while only one study [14] reported a higher percentage of chronic pain.…”

Section: Resultsmentioning

confidence: 98%

“…However, only five trials reported the recurrence. The recurrence rate in these trails was 1.79% [11], 0.95% [9], 1.35% [8], 0.38% [14] and 0.98% [15], respectively, with the follow-up of 6 to 15 months. One trial [8] determined the recurrence by clinical examination, while others didn't provide specific methods.…”

Section: Resultsmentioning

confidence: 99%

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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 Tisseel/Tissucol for Mesh Fixation in Patients Undergoing Lichtenstein Technique for Primary Inguinal Hernia Repair

Abstract: 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).

Cited by 104 publications

References 26 publications

Intraoperative nerve identification and chronic postherniorrhaphy pain

Intraoperative nerve identification and chronic postherniorrhaphy pain

Update with level 1 studies of the European Hernia Society guidelines on the treatment of inguinal hernia in adult patients

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

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