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. 2021 May 28;2021(5):CD011563. doi: 10.1002/14651858.CD011563.pub2

Muysoms 2013.

Study characteristics
Methods Randomised controlled trial
Location
International multicenter, Spain and Belgium
Study dates 
Between December 2004 and July 2008
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
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
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
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