Muysoms 2013.
Study characteristics | ||
Methods | Randomised controlled trial Location International multicenter, Spain and Belgium Study dates Between December 2004 and July 2008 |
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Participants |
Inclusion/exclusion criteria Primary and incisional ventral hernias. Parastomal hernias and all hernias close to bony structures, like suprapubic, subxiphoidal, subcostal hernias, and lumbar hernias were excluded Patient characteristics (nonabsorbable tacks with nonabsorbable sutures (43) / nonabsorbable tacks only (33)) Age (mean, SD): 56.7 (16.2) / 59.8 (9.4) Gender (male, %): 52 / 59 BMI (kg/m2, mean, range): 29.6 (6.5) / 29.3 (4.7) Hernia type (incisional, %): 72 / 78 Hernia size (mean, SD, cm2): 45.6 (50.6) / 46.5 (55.4) Comorbidity: NR |
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Interventions | Intervention/control: nonabsorbable tacks (1 – 2 cm distance) with nonabsorbable sutures compared to nonabsorbable tacks (double crown, 1 – 2 cm distance) Mesh: different meshes in the centres Intra‐abdominal mesh position: intra‐peritoneal Surgical approach: laparoscopic |
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Outcomes | Recurrence (follow‐up 2 years), pain (primary outcome), return to activity, local infection, seroma, haematoma, length of hospital stay, duration of surgery | |
Notes |
Funding source(as originally reported) This study was performed with a research grant from WL Gore & Ass, Flagstaff, USA Declarations of interest for the primary investigators (as originally reported) The co‐authors declare no conflict of interest. Data for sensitivity analyses Randomised: 43/33 Analysed: 36/27 Imputed in ITT sensitivity analysis: 7/6 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | MS Excel random function |
Allocation concealment (selection bias) | Low risk | Allocation of a specific participant was sent to the surgeon after receiving the informed consent |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Surgeon not blinded. Other caregivers and participants unclear |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported. Tendentially recurrence "lower risk" (objective outcome), pain "higher risk" (subjective outcome) |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not all randomised participants analysed. No information on reasons for dropout |
Selective reporting (reporting bias) | Low risk | The study protocol is not available but it seems that the published reports include all expected outcomes, including those that were prespecified |
Other bias | Low risk | None detected |