| Methods |
Single centre, three arms RCT of Shouldice vs Lichtenstein vs Mc Vay.
Randomization: generation of sequence by random digit table; allocation list maintained by a person unassociated with the study.
Follow up: 7 years.
Exclusions after randomizations: not reported.
Losses to follow up: 29 (could not be contacted).
Analyses by protocol.
Jadad quality score: 4. |
| Participants |
Country: USA.
Setting: centre not specialized in hernia repair.
Total enrolled patients: 146. Three arms: 150 hernias (52 Shouldice, 49 Lichtenstein and 49 Mc Vay).
Mean age: 62 Shouldice, 63 Lichtenstein, 65 Mc Vay.
Gender: 146 M.
Inclusion criteria: Primary inguinal hernia.
Exclusion criteria: age <18 years, use of systemic steroids, incarcerated hernia, recurrent hernia, collagen or vascular disease, ASA 4 or 5, allergy to acetaminophen or codeine.
Demographic and baseline data reported: comparability for sex, COPD, prostatism and constipation. |
| Interventions |
Shouldice modified (n=41). 4 layers. Polypropylene.
Lichtenstein standard (n=39).
McVay standard (n=41). |
| Outcomes |
Recurrence (lump in groin not necessarily re‐operated).
Lenght of postoperative stay.
Postoperative satisfaction level.
Wound infection.
Haematoma.
Duration of the operation. |
| Notes |
Recurrence at 6‐9 years follow up assessed by clinical examination in 121 patients(29 lost at follow up).
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 |
