| Methods |
Single centre, two arms RCT of Shouldice vs Plication Darn (Bassini modified).
Randomization: generation of sequence not stated, allocation concealment: randomizations just before skin incision.
Maximum follow up: 2 years.
Exclusions after randomizations: no.
Intention to treat analyses.
Losses to follow up: 98 (reasons not specified).
Jadad quality score: 3. |
| Participants |
Country: UK.
Setting: centre not specialized in hernia repair.
Total enrolled patients: 322; 322 hernias (151 Shouldice vs 171 Plication Darn).
Mean age: Shouldice 58,3; Plication Darn 57.
Gender: 304 M; 18 F
Inclusion criteria: age>18, primary inguinal hernia, elective repair.
Exclusion criteria: no known.
Demographic and baseline data reported: comparability for age, type of hernia, sex (all data reported). |
| Interventions |
Shouldice (n=151). Technical notes not specified.
Plication Darn (Bassini modified) (n=171). |
| Outcomes |
Recurrence (definition of recurrence not reported).
Lenght of postoperative stay.
Wound infection.
Haematoma. |
| Notes |
Recurrence at 2 years follow up assessed by a consultant or a surgical registrar or pro forma in 224 patients.
Recurrence at 4 years follow up only in 61 (18,9%) patients so data from this follow up will not be considered.
Conflict of interest: not reported.
Sources of funding: not reported. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
