| Methods |
Single centre, three arms RCT ‐ comparisons: Shouldice vs Plug and patch vs TAPP (not considered for the analyses).
Randomization: computer generated. Allocation concealment not specified.
Maximum follow up: 25 months.
Exclusions after randomizations: not reported.
Analyses by protocol
Losses to follow up: none.
Jadad quality score: 3. |
| Participants |
Country: Germany.
Setting: centre not specialized in hernia repair.
Total enrolled patients: 160 (80 for each group)
Mean age (SD): Shouldice 46 (15); Plug and Patch 47 (14).
Gender:147 M, 13 F.
Inclusion criteria: Primary inguinal hernia repair, age >18.
Exclusion criteria: incarcerated hernias, coagulation disorders, contraindication for general anaesthesia, cardiac insufficiency (NYHA 3‐4).
Demographic and baseline data: comparability for age, sex, type of hernia (Nyhus), occupation, BMI (all data reported). |
| Interventions |
Shouldice modified (n=80). 4 layers. Unabsorbable monofilament.
Plug and Patch (n=80). Polypropylene meshes and plugs. |
| Outcomes |
Recurrence (method not stated).
Lenght of postoperative stay.
Chronic pain.
Wound Infection.
Seroma.
Haematoma.
Duration of operation. |
| Notes |
Recurrence at 25 months assessed for 96% of Shouldice group and 94% of Plug and Patch.
Conflict of interest: not reported.
Sources of funding: not reported. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
