Bracale 2012.

Methods	Prospective multicentric parallel randomized controlled trial. A randomization was achieved by computer‐generated random numbers. The participants were blinded to group assignment. Unilateral hernia. Country: Italy. Setting: 3 hospitals in 3 different Italian towns: University Hospital "Federico II" in Naples, "San Camillo" Hospital in Trento and Cairo Montenotte Hospital. Enrollment dates: from January 2009 to June 2010.
Participants	Inclusion criteria: Adult subjects ( ≥ 18 years) of both genders with primary uncomplicated inguinal hernia (classified by Rutkow and Robbins classification) suitable for LT were included in this study. Exclusion criteria: Immunological or coagulation disorders, steroid therapy and psychiatric disorders, and refusal to give informed consent. Glue group: 50 participants Median age: 59 yrs. Male: 96% ASA: I (52%); II (36%); III (12%) Median BMI: 25.97 Hernia location: Right (58%); Left (42%) Direct:indirect: not reported. Hernia classification: I (38%); II (32%); IV (30%) Suture group: 52 participants Median age: 56 yrs. Male: 94% ASA: I (56%); II (38%); III (6%) Median BMI: 25.86 Hernia location: Right (53.9%); Left (46.1%) Direct:indirect: not reported. Hernia classification: I (28.8%); II (28.8%); IV (36.5%); V (5.8%)
Interventions	Lichtenstein inguinal hernioplasty with ULTRAPRO® (Ethicon Products, Sommerville NJ, USA A semi‐absorbable lightweight mesh), 11 cm × 6 cm. Glue group: Fibrin sealant (QUIXIL®, Omrix Biopharmaceuticals S.A., Belgium); Suture group: Prolene N° 3–0
Outcomes	Recurrences, chronic pain, numbness, overall postoperative complications (e.g. haematoma, ecchymosis, seroma, infection), length of operation, time to discharge, cost analysis
Notes	Handling of nerves: Nerves are preserved if possible. Length of follow‐up: 15 month (range 12 to 18). Time points of the analysis: 6 months for chronic pain and the last day of follow‐up for recurrence. Intention‐to‐treat analysis: yes. The number of participants randomized: 50 in Glue group; 52 in Suture group The number of patients evaluated: 50 in Glue group; 52 in Suture group Information from publication only. The authors declare that they have no conflict of interest. No details of funding sources provided.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	A randomization was achieved by computer‐generated random numbers with block sizes and an allocation ratio of 1:1 that allowed balance recruitment within each centre.
Allocation concealment (selection bias)	Low risk	The random allocations were placed into shuffled, numbered, sealed, opaque envelopes at the beginning of the study before the inclusion of the first subject. The envelopes were opened during the operation just before mesh fixation.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	The participants were blinded to group assignment.
Blinding of outcome assessment (detection bias) All outcomes	High risk	This was a single‐blinded study as the evaluators were not completely blinded to treatment. Evaluators for post discharge and follow‐up outcomes were blinded, but some surgeons participated in the evaluation process.
Incomplete outcome data (attrition bias) All outcomes	Low risk	The proportion of missing outcomes compared with observed event was not big enough to have a clinically relevant impact on the intervention effect estimate (Only 2 participants were lost to follow‐up at the twelfth month)
Selective reporting (reporting bias)	Low risk	It is clear that the published reports include all expected outcomes.
Other bias	Unclear risk	Not clear. Without details of funding sources.