Fibrin glue does not improve healing of gastrointestinal anastomoses: a systematic review
Nordentoft T, Pommergaard HC, Rosenberg J, Achiam MP
European Surgical Research. 2015;54((1-2):):1-13.
BACKGROUND/AIM: Anastomotic leakage remains a frequent and serious complication in gastrointestinal surgery. In order to reduce its incidence, several clinical and experimental studies on anastomotic sealing have been performed. In a number of these studies, the sealing material has been fibrin glue (FG), and the results in individual studies have been varying. The positive effect of anastomotic sealing with FG might be due to the mechanical/physical properties, the increased healing of the anastomoses or both. The aim of this systematic review was to evaluate the existing evidence on the healing effects of FG on gastrointestinal anastomoses. METHODS PubMed, EMBASE and the Cochrane databases were searched for studies evaluating the healing process of gastrointestinal anastomoses after any kind of FG application. The search period was from 1953 to December 2013. RESULTS Twenty-eight studies were included in the qualitative synthesis. These studies were all experimental studies, since no human studies used histological or biochemical evaluation of healing. In 7 of the 28 studies, a positive effect of FG on healing was found, while 8 studies reported a negative effect and 11 studies found no effect. Furthermore, 2 studies reported unclear results. The difference in the study outcome was independent of the study design and the type of FG used. CONCLUSION In the available studies, FG did not consistently have a positive influence on the healing of gastrointestinal anastomoses. It is consequently plausible that the positive effect of FG sealing of gastrointestinal anastomoses, if there is any, may be due to a mechanical sealing effect rather than due to improved healing per se. 2014 S. Karger AG, Basel.
Post-operative benefits of Tisseel/Tissucol for mesh fixation in patients undergoing Lichtenstein inguinal hernia repair: secondary results from the TIMELI trial
Campanelli G, Pascual MH, Hoeferlin A, Rosenberg J, Champault G, Kingsnorth A, Bagot d'Arc M, Miserez M
PURPOSE The Tisseel/Tissucol for mesh fixation in Lichtenstein hernia repair (TIMELI) study showed that mesh fixation with human fibrin sealant during inguinal hernia repair significantly reduced moderate-severe complications of pain 12 months post-operatively compared with sutures. Further analyses may assist surgeons by investigating predictors of post-surgical complications and identifying patients that may benefit from Tisseel/Tissucol intervention. METHODS Univariate and multivariate analyses identified risk factors for combined pain, numbness and groin discomfort (PND) visual analogue scale (VAS) score 12 months post-operatively. Variables tested were: fixation method, age, employment status, physical activity, nerve handling, PND VAS score at pre-operative visit and 1 week post-operatively. The effect of fixation technique on separate PND outcomes 12 months post-surgery was also assessed. Analyses included the intention-to-treat (ITT) population and a subpopulation with pre-operative PND VAS > 30 mm. RESULTS 316 patients were included in the ITT, with 130 patients in the subpopulation with pre-operative PND VAS > 30. Multivariate analysis identified mesh fixation with sutures, worsening pre-operative PND and worsening PND 1 week post-surgery as significant predictors of 12-month PND in the ITT population; mesh fixation with sutures was a significant predictor of 12-month PND in the pre-operative PND VAS > 30 subpopulation (p < 0.05). Mesh fixation with Tisseel/Tissucol resulted in significantly less numbness and a lower intensity of groin discomfort compared with sutures at 12 months; there was no difference in pain between the treatment groups. CONCLUSIONS Pre-operative discomfort may be an important predictor of post-operative pain, numbness and discomfort. Tisseel/Tissucol may improve long-term morbidity over conventional sutures in these patients.
Randomized clinical trial of fibrin glue versus tacked fixation in laparoscopic groin hernia repair
Tolver MA, Rosenberg J, Juul P, Bisgaard T
Surgical Endoscopy. 2013;27((8):):2727-33, 2734..
BACKGROUND Preliminary studies have indicated clinical advantages of mesh fixation using fibrin glue in transabdominal preperitoneal groin hernia repair (TAPP)compared with tack fixation. The aim of this randomized double-blinded, controlled, clinical trial is to compare fibrin glue with tacks fixation of mesh during TAPP. METHODS One hundred and twelve men with unilateral inguinal hernia were enrolled. Primary outcome was pain during coughing on postoperative day 1. Secondary outcomes were postoperative scores of pain at rest, discomfort, and fatigue (day 1 and cumulated day 0-3), incidence of moderate/severe nausea and/or vomiting, foreign-body sensation, and recurrence after 6months. Outcome measures were assessed by visual analogue scale (VAS, 0-100mm), verbal rating scale (no, light, moderate or severe) and numerical rating scales (NRS, 1-10). RESULTS One hundred patients were available for analysis. The fibrin group (n=50) had significantly less pain during coughing on day 1 compared with the tacks group (n=50) [median 23 (range 0-80) vs 35 (2-100) mm] (p=0.020). Moreover, day 1 scores and all cumulated scores of pain during rest, discomfort, and fatigue were significantly lower in the fibrin group compared with the tacks group (all p-values<=0.02). There was no significant difference in the incidence of nausea and/or vomiting (p>0.05) or recurrence (fibrin glue n=2, tacks n=0, p=0.241). Incidence of foreign-body sensation was significantly lower in the fibrin group at 1month (p=0.006). CONCLUSIONS Fibrin glue compared with tacks fixation improved the early postoperative outcome after TAPP. The trial was registered at clinicaltrials.gov NCT01000116.
Fibrin sealant for mesh fixation in laparoscopic umbilical hernia repair: 1-year results of a randomized controlled double-blinded study
Eriksen JR, Bisgaard T, Assaadzadeh S, Jorgensen LN, Rosenberg J
PURPOSE Fibrin sealant for mesh fixation has significant positive effects on early outcome after laparoscopic ventral hernia repair (LVHR) compared with titanium tacks. Whether fibrin sealant fixation also results in better long-term outcome is unknown. METHODS We performed a randomized controlled trial including patients with umbilical hernia defects from 1.5 to 5cm at three Danish hernia centres. We used a 12cm circular mesh. Participants were randomized to fibrin sealant or titanium tack fixation. Patients were seen in the outpatient clinic at 1 and 12 months follow-up. RESULTS Forty patients were included of whom 34 were available for intention to treat analysis after 1year. There were no significant differences in pain, discomfort, fatigue, satisfaction or quality of life between the two groups at the 1-year follow-up. Five patients (26%) in the fibrin sealant group and one (6%) in the tack group were diagnosed with a recurrence at the 1-year follow-up (p=0.182) (overall recurrence rate 17%). Hernia defects in patients with recurrence were significantly larger than in those without recurrence (median 4.0 vs. 2.8 cm, p=0.009). CONCLUSION Patients with larger hernia defects and fibrin sealant mesh fixation had higher recurrence rates than expected, although the study was not powered for assessment of recurrence. There was no significant difference between groups in any parameters after the 1-year follow-up. The beneficial effects of mesh fixation with fibrin sealant on early outcome warrant further studies on optimization of the surgical technique to prevent recurrence.
Randomized, controlled, blinded trial of tisseel/tissucol for mesh fixation in patients undergoing Lichtenstein technique for primary inguinal hernia repair: results of the TIMELI trial
Campanelli G, Pascual MH, Hoeferlin A, Rosenberg J, Champault G, Kingsnorth A
Annals of Surgery. 2012;255((4):):650-7.
Objective: Test the hypothesis that fibrin sealant mesh fixation can reduce the incidence of postoperative pain/numbness/groin discomfort by up to 50% compared with sutures for repair of inguinal hernias using the Lichtenstein technique. Background: Inguinal hernia repair is the most common procedure in general surgery, thus improvements in surgical techniques, which reduce the burden of undesirable postoperative outcomes, are of clinical importance. Methods: A randomized, controlled, patient- and evaluator-blinded study (Tissucol/Tisseel for MEsh fixation in LIchtenstein hernia repair [TIMELI]; trial NCT00306839) was conducted among patients eligible for Lichtenstein repair of uncomplicated unilateral primary inguinal small-medium sized hernia. Patients were subject to mesh fixation with either fibrin sealant or sutures. Main outcome measures were visual analogue scale (VAS) assessments for pain,numbness,and groin discomforton a scale of 0 = best and 100 = worst outcome. The primary endpoint was a composite that evaluated the prevalence of chronic disabling complications (VAS score >30 for pain/numbness/groin discomfort) at 12 months after surgery. Results: In total, 319 patients were randomized between January 2006 and April 2007 (159 fibrin sealant, 160 sutures). At 12 months, the prevalence of 1 or more disabling complication was significantly lower in the fibrin sealant group than in the sutures group (8.1% vs 14.8%; P = 0.0344). Less pain was reported in the fibrin sealant group than in the sutures group at 1 and 6 months (P = 0.0132; P = 0.0052), as reflected by a lower proportion of patients using analgesics in the fibrin group over the study duration (65.2% vs 79.7%; P = 0.0009). Only 3 of 316 patients (0.9%) experienced recurrence. The incidences of wound-healing complications and other adverse events were comparable between groups. Conclusions: 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). (C) 2012 Lippincott Williams & Wilkins, Inc.
Randomized clinical trial of fibrin sealant versus titanium tacks for mesh fixation in laparoscopic umbilical hernia repair
Eriksen JR, Bisgaard T, Assaadzadeh S, Jorgensen LN, Rosenberg J
The British Journal of Surgery. 2011;98((11):):1537-45.
BACKGROUND The use of tacks for mesh fixation may induce pain after surgery for ventral hernia. The aim of this study was to compare postoperative pain after laparoscopic ventral hernia repair (LVHR) with conventional mesh fixation using titanium tacks versus fibrin sealant (FS). METHODS This randomized clinical trial included patients with an umbilical hernia defect ranging from 1·5 to 5 cm at three Danish hernia centres. Participants were assigned randomly to FS or titanium tack fixation. The primary outcome was acute pain, defined as the mean pain score on days 0-2 after surgery, measured on a 0-100-mm visual analogue scale (VAS). RESULTS Forty patients were included, of whom 38 were available for intention-to-treat analysis after 1 month. Patients in the FS group reported less pain than those in the tack group on days 0-2, both at rest (median 19 versus 47 mm; P = 0·025) and during activity (38 versus 60 mm; P = 0·014). The absolute difference in pain score between groups was 19 (95 per cent confidence interval 3 to 34) and 20 (4 to 35) mm at rest and during activity respectively. Patients in the FS group resumed normal daily activity earlier (after median 7 versus 18 days; P = 0·027) and reported significantly less discomfort. No recurrences were observed. CONCLUSION Mesh fixation with FS in LVHR was associated with less acute postoperative pain, discomfort and a shorter convalescence than tack fixation. Long-term follow-up is needed to show whether the effect of FS fixation persists in terms of chronic pain and recurrence. Registration number: NCT00842842 (http://www.clinicaltrials.gov).
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 MH, Hoeferlin A, Kingsnorth A, Rosenberg J, Miserez M
BACKGROUND Complications associated with sutured mesh fixation following open groin hernia repair have prompted surgeons to evaluate methods of atraumatic fixation such as the use of human fibrin glue. Small trials with Tissucol/Tisseel fibrin glue (Baxter Healthcare, Deerfield, IL, USA) have shown promising results that warrant further investigation. METHODS TIMELI (Tissucol/Tisseel for MEsh fixation in LIchtenstein hernia repair) is an international, controlled, randomized, patient- and evaluator-blinded study that is comparing mesh fixation with Tissucol or sutures in patients with inguinal hernia. The primary endpoint evaluates the incidence of disabling complications (chronic pain and/or numbness and/or groin discomfort) at 12 months post-surgery. RESULTS Patient enrolment started in February 2006 and ended on 19 April 2007, with a total of 325 patients recruited. Initial results are expected in early 2008. CONCLUSIONS 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.