Kim‐Fuchs 2012.
Methods | Two‐armed randomized trial. Randomized by numbered sealed envelopes. The trial was unblinded. Unilateral hernia. Country: Switzerland. Setting: Kantonspital Aarau, Switzerland. Enrolment dates: between January 2001 and December 2004. |
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Participants | Inclusion criteria:
Exclusion criteria:
131 participants with mean age of 55.1 (28 to 85) years in Glue group 133 participants with mean age of 56.8 (25 to 83) years in Suture group. Sex: not reported. Direct:indirect: not reported. Right:left: not reported. |
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Interventions | Lichtenstein inguinal hernioplasty with VIPRO II (lightweight, Ethicon, Johnson & Johnson Medical Products, Vienna, Austria). Glue group:
Suture group:
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Outcomes | Haematoma, hospital stay, hypersthesia, chronic pain, hernia recurrence, hospital length of stay, length of operation, mesh infection. | |
Notes | Handling of nerves:
Length of follow‐up: 5 years. Time points of the analysis: 3 months for chronic pain and 5 year for recurrence. Intention‐to‐treat analysis: no. The number of participants randomized: 131 in Glue group; 133 in Suture group The number of participants evaluated: 129 in Glue group; 131 in Suture group Registered with the Swiss Federal Office of Public Health (SFOPH‐99‐0021). Information from publication only. No details of funding sources and any declarations of interest provided. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not clear. |
Allocation concealment (selection bias) | Low risk | Randomized by numbered sealed envelopes. The envelope was opened intraoperatively after the hernia was classified. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | The trial was unblinded. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | The trial was unblinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | After 3 months, 2 participants in each group were lost to follow‐up, after 12 months 13 in group I and 17 in group II. After 5 years, 33 participants were lost in group I and 41 in group II. But the proportion of missing outcomes is comparable between the 2 groups. |
Selective reporting (reporting bias) | Low risk | It is clear that the published reports include all expected outcomes. |
Other bias | Unclear risk | Not clear. Without details of funding sources and any declarations of interest. |