Butters 2007.
Methods | Two‐hundred and eighty (280) men with a primary hernia were randomised prospectively to undergo Shouldice/suture (93), open Lichtenstein/mesh (93), or laparoscopic TAPP/mesh (94) repair. Participants were examined after 12 and 52 months to assess hernia recurrence, nerve damage, testicular atrophy and patient satisfaction. | |
Participants | Any adult male (defined as greater than the age of 18) that had a primary unilateral inguinal hernia was eligible for this study. | |
Interventions | The laparoscopic TAPP and open Lichestein procedure uses mesh in their repair, and the Shouldice procedure utilises sutures.
All participants were operated under general anaesthesia and received one prophylactic dose of amoxicillin/clavulanic‐acid preoperatively. |
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Outcomes | Follow‐up at 52 months, assessing:
Follow‐up at 12 months, assessing:
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Notes | This study found that hernia recurrence occurred in six participants after Shouldice suture repair, and in one patient each after Lichtenstein and TAPP mesh repairs at the 52 month endpoint. Furthermore, all recurrences after tension‐free mesh repairs were diagnosed within the first year after surgery. Nerve injuries were significantly more frequent after open Shouldice and Lichtenstein repairs, with greatest patient satisfaction after laparoscopic TAPP repair. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | In a time interval of 12 months, 280 male participants with inguinal hernias were selected and randomly assigned to three different groups. However, it is noted that the study authors did not disclose how they achieved randomisation (for example, if it was through computer generation or otherwise). |
Allocation concealment (selection bias) | Unclear risk | The results of the randomisation were delivered via sealed opaque envelopes to the participants. However, it is not clarified whether or not the study authors were involved in the allocation process or made privy to the participant details. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | There was no information in the published journal of the study regarding attempts at blinding either the participants or personnel assessing outcomes. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | There was no information in the published journal of the study regarding attempts at blinding either the participants or personnel assessing outcomes. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants from the study were accounted for. A total of 49 participants were lost to follow‐up at the 52 month mark, which included 14 deaths that may not be reasonably attributable to the intervention. |
Selective reporting (reporting bias) | Low risk | All outcomes were fairly reported and discussed in all participants that were able to be followed‐up. |
Other bias | Low risk | No other significant biases were noted. |