Butters 2007.
Methods | Single centre, three arms RCT ‐ Conparisons: Shouldice vs Lichtenstein vs TAPP (not considered). Randomization: generation of sequence not stated, Allocation concealment using sealed envelopes. Maximum follow up: 52 months. Exclusion after randomizations: no. Losses to follow up: Shouldice 19, Lichtenstein 17 (9 deaths, 5 moved to other places and 22 refused to continue). Analyses by protocol | |
Participants | Country: Germany. Setting: centre specialized in hernia repair. Total enrolled patients: 186 (93 Shouldice vs 93 Lichtenstein). Mean age: Shouldice: 53; Lichtenstein 56. Gender: 186 M. Inclusion criteria: age >18, primary inguinal hernia, elective repair. Exclusion criteria: no known. Demographic and baseline data reported: comparability for age, type of hernia. | |
Interventions | Shouldice (n=93). Technical notes not specified. Lictenstein standard (n=93). | |
Outcomes | Recurrence (definition of recurrence not reported). Chronic pain (data from Koninger 2004). Postoperative satisfaction level Testicular atrophy |
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Notes | 52 months follow up assessed by a resident surgeon by physical examination in 150 patients (80.6%) Conflict of interest: not reported. Sources of funding: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Low risk | A ‐ Adequate |