Showing papers by "Giampiero Campanelli published in 2012"

EuraHS: the development of an international online platform for registration and outcome measurement of ventral abdominal wall hernia repair.

Abstract: Although the repair of ventral abdominal wall hernias is one of the most commonly performed operations, many aspects of their treatment are still under debate or poorly studied. In addition, there is a lack of good definitions and classifications that make the evaluation of studies and meta-analyses in this field of surgery difficult. Under the auspices of the board of the European Hernia Society and following the previously published classifications on inguinal and on ventral hernias, a working group was formed to create an online platform for registration and outcome measurement of operations for ventral abdominal wall hernias. Development of such a registry involved reaching agreement about clear definitions and classifications on patient variables, surgical procedures and mesh materials used, as well as outcome parameters. The EuraHS working group (European registry for abdominal wall hernias) comprised of a multinational European expert panel with specific interest in abdominal wall hernias. Over five working group meetings, consensus was reached on definitions for the data to be recorded in the registry. A set of well-described definitions was made. The previously reported EHS classifications of hernias will be used. Risk factors for recurrences and co-morbidities of patients were listed. A new severity of comorbidity score was defined. Post-operative complications were classified according to existing classifications as described for other fields of surgery. A new 3-dimensional numerical quality-of-life score, EuraHS-QoL score, was defined. An online platform is created based on the definitions and classifications, which can be used by individual surgeons, surgical teams or for multicentre studies. A EuraHS website is constructed with easy access to all the definitions, classifications and results from the database. An online platform for registration and outcome measurement of abdominal wall hernia repairs with clear definitions and classifications is offered to the surgical community. It is hoped that this registry could lead to better evidence-based guidelines for treatment of abdominal wall hernias based on hernia variables, patient variables, available hernia repair materials and techniques.

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

Abstract: 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 discomfort" on 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).

Reducing postoperative pain: the use of Tisseel for mesh fixation in inguinal hernia repair.

Abstract: INTRODUCTION The new objective in primary hernia surgery should be the reduction of disabling chronic pain. This article will discuss the safety, efficacy, and reduction of pain of a sutureless glue mesh procedure for primary uncomplicated inguinal hernia repair. METHODS We began performing sutureless glue mesh repairs in 2004 for primary uncomplicated inguinal hernias with good results. After reduction of the hernia sac, polypropylene medium-weight preshaped flat mesh is fixed to the posterior inguinal wall with 0.5 mL of fibrin glue on the pubic tubercle; another 1.5 mL is sprayed on the entire mesh surface. The cord is positioned in subcutaneous space. The TI.ME.LI (Tissucol/Tisseel for MEsh fixation in LIchtenstein hernia repair) trial was planned and conducted based on this experience. RESULTS In two years, we treated more than 600 primary inguinal hernias with fibrin glue mesh fixation repair. At follow-up (2 to 96 months after surgery), no patients presented with severe pain, 2.7% of patients complained of moderate pain. CONCLUSION Fibrin sealant for mesh fixation in open repair is well tolerated and it should be considered as a first-line option for mesh fixation in open inguinal hernia repair.