Methods |
Multicenter, two arms RCT of Shouldice vs Lichtenstein.
Randomization: Day of intervention. Allocation concealment inadequate.
Maximum follow up: 3 months.
Exclusions after randomizations: 562 hernias (randomizations performed before evaluation of inclusion criteria).
Analyses by protocol.
Losses to follow up: none.
Jadad quality score: 1. |
Participants |
Country: Switzerland.
Setting: centres not specialized in hernia repair.
Total enrolled patients (two arms): 385 patients; number of hernias: 410 (171 Shouldice vs 239 Lichtenstein).
Mean age (SD): Shouldice 53 (16,77); Lichtenstein 58 (17,36).
Gender: 385 M.
Inclusion criteria: age>18, primary inguinal hernia, elective repair.
Exclusion criteria: incarcerated hernia, previous operation in the inguinal region, coagulopathy, diabetes, prostatic hyperplasia, wish for general anaesthesia.
Demographic and baseline data reported: comparability for age, type of hernia(all data reported). |
Interventions |
Shouldice Standard (n=171). 4 layers. PDS 2/0.
Lichtenstein (n=239). Polypropylene meshes. Polypropylene 2/0. |
Outcomes |
Lenght of postoperative stay.
Wound Infection.
Duration of operation. |
Notes |
Conflict of interest: not reported.
Sources of funding: not reported. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment (selection bias) |
High risk |
C ‐ Inadequate |