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.

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.

The European hernia society groin hernia classification: simple and easy to remember.

After reviewing the available classifications for groin hernias, the European Hernia Society (EHS) proposes an easy and simple classification based on the Aachen classification. The EHS will promote the general and systematic use of this classification for intraoperative description of the type of hernia and to increase the comparison of results in the literature.

Use of icodextrin 4% solution in the prevention of adhesion formation following general surgery: from the multicentre ARIEL Registry.

INTRODUCTION: Intra-abdominal adhesions occur in many patients following major abdominal surgery and represent a serious burden to patients and healthcare providers. The multicentre ARIEL (Adept Registry for Clinical Evaluation) Registry was established to gather clinical experiences in the use of icodextrin 4% solution, an approved adhesion-reduction agent, during routine general surgery. PATIENTS AND METHODS: General surgeons from five European countries completed anonymised data collection forms for patients undergoing laparotomy or laparoscopy. Surgeons recorded patient demographics, use of icodextrin 4% solution and adverse events, and made subjective assessments of ease of use and patient acceptability with the agent. RESULTS: The general surgery registry included 1738 patients (1469 laparotomies, 269 laparoscopies). Leakage of fluid from the surgical site did not appear to be affected by icodextrin 4% solution and was classified as 'normal' or 'less than normal' in most patients (laparotomies 86%, laparoscopies 88%). Overall, satisfaction with ease of use was rated as 'good' or 'excellent' by the majority of surgeons (laparotomies 77%, laparoscopies 86%). Patient acceptability was also good, with ratings of 'as expected' or 'less than expected' in most cases for both abdominal distension (laparotomies 90%, laparoscopies 91%) and abdominal discomfort (laparotomies 91%, laparoscopies 93%). Adverse events occurred in 30.6% of laparotomy patients and 16.7% of laparoscopy patients; the most common events were septic/infective events (4.2% and 3.4% in the laparotomy and laparoscopy groups, respectively). Anastomotic wound-healing problems were reported in 7.6% of patients in the subset of laparoscopy patients undergoing anastomotic procedures (n = 66). DISCUSSION: Volumes of icodextrin 4% solution used as an irrigant and instillate were in line with recommendations. Surgeons considered the agent to be easy to use and acceptable to patients. The reported frequencies of adverse events were in line with those published in the literature for surgical procedures, supporting the good safety profile of this agent. CONCLUSIONS: Icodextrin 4% solution can be used in a wide range of surgical procedures. In combination with good surgical technique, it may play an important role in adhesion reduction.