| Methods |
Single centre, two arms RCT of Shouldice vs Lichtenstein.
Randomization: generation sequence by computer generated in blocks of ten patients, allocation concealment not specified.
Maximum follow up: 6 years.
Exclusions after randomizations: 2 patients refused to continue, 1 hernia not found.
Losses to follow up: 9 (reasons not specified).
Intention to treat analyses
Jadad quality score: 3. |
| Participants |
Country: Sweden.
Setting: centre not specialized in hernia repair.
Total enrolled patients: 300. 297 hernias (148 Shouldice 149 Lichtenstein).
Age range: 25‐75.
Gender: 300 M.
Inclusion criteria: age >18, primary inguinal hernia.
Exclusion criteria: irreducibility of hernia, coagulation abnormalities or anticoagulant treatment.
Demographic and baseline data: comparability for age, type of hernia, activities, testicular preoperative size (data not reported). |
| Interventions |
Shouldice Standard (n=148). 4 layers. Polypropylene 2/0.
Lichtenstein (n=149). Marlex meshes. Polypropylene 2/0. |
| Outcomes |
Recurrence (lump in groin not necessarily re operated).
Lenght of postoperative stay.
Chronic pain.
Wound infection.
Seroma.
Testicular atrophy.
Haematoma.
Duration of operation. |
| Notes |
Recurrence at 3‐6 years follow up assessed by an independent surgeon in 284 patients.
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 |
