| Methods |
Single centre, two arms RCT of Shouldice vs Lichtenstein.
Randomization: coin toss, allocation concealment inadequate.
Maximum follow up: 5 years.
Exclusion after randomizations: 31 (patients decided to undergo a laparoscopic repair).
Intention to treat analyses.
Losses to follow up: 251(35,5%)
Jadad quality score: 1. |
| Participants |
Country: USA
Setting: private centre specialized in hernia repair.
Total enrolled patients: 672. 717 hernias.
Mean age (SD): data not reported
Gender: 672 M.
Inclusion criteria: inguinal hernia.
Demographic and baseline data reported: comparability for sex, age, activity (data not reported). |
| Interventions |
Shouldice standard (n=337) performing 4 layers. Non‐absorbable monofilament.
Lichtenstein standard (n=371). Polypropylene Mesh. |
| Outcomes |
Recurrence
Chronic pain
Wound infection
Testicular atrophy |
| Notes |
Recurrence at 5 years follow up assessed by the operating surgeon in 99% of patients.
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 |
