Prieto‐Diaz‐Chavez 2009.
Methods | One hundred and six (106) participants with an inguinal hernia were randomised into an open‐tension (Shouldice) (52) or mesh‐plug tension‐free (MPTF) (54) hernia repair and were followed up at a two‐year interval. | |
Participants | Participants between the ages of 18 and 65 years scheduled for a unilateral, primary or first‐recurrence inguinal hernia repair procedure at the General Hospital of Colima/Mexican Institute of Social Security, Colima, Mexico. Participants with irreducible hernias, morbid obesity, severe comorbidities, history of substance abuse, pregnancy, bilateral or more than one recurrence of hernias were excluded. | |
Interventions | Open‐tension (Shouldice) or mesh‐plug tension‐free (MPTF) | |
Outcomes | Outcomes included the following.
Follow‐up assessment was performed at 7 days, 8 weeks, 12 and 24 months. |
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Notes | Surgery time, time to full recovery, pain VAS, use of analgesia, off‐work time and hospital stay were all significantly lower for the MPTF repair. Disability adjusted life years were reduced 56% with the MPTF repair, which represented a total savings of USD 12656.60 with this procedure compared to Shouldice repair. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomly assigned numbers according to a computer‐generated random‐number table to receive one of the two techniques. |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment technique is not described. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | The appropriate hernioplasty group was known at the operating room, and all participating personnel as well as the investigator performing result analysis were blinded to the assigned procedure. The blinding technique is not discussed in any further detail. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Follow‐up was performed by the study surgeon. As a result, we must assume that the assessor was aware of the allocated surgery for each participant. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information was provided regarding participant loss‐to‐follow up or intention‐to‐treat analysis. |
Selective reporting (reporting bias) | Low risk | All outcomes were reported and discussed. |
Other bias | Low risk | None identified. |