Bansal 2012.
| Study characteristics | ||
| Methods | Randomised controlled trial Location Department of Surgical Disciplines, All India Institute of Medical Sciences, New Delhi, India Study dates Between May 2007 and December 2011 |
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| Participants |
Inclusion criteria Non‐recurrent primary or incisional ventral hernia (defect size of 2 ‐ 5 cm) without significant comorbidity Patient characteristics (nonabsorbable tacks with nonabsorbable sutures (55) / nonabsorbable sutures only (55)) Age (mean, SD): 45.9 (10.6) / 44.6 (13.6) Gender (male, %): 21.8 / 40.0 BMI (kg/m2, mean, SD): 29.3 (5.0) / 28.2 (5.3) Hernia type (incisional, %): 61.8 / 58.2 Hernia size (mean, SD, cm2): 189.7 (71.5) / 178.5 (70.8) Comorbidity: NR |
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| Interventions | Intervention/control: suture (transfascial) fixation with nonabsorbable tacks (double crown, 1 – 2 cm distance) versus suture fixation (polypropylene) Mesh: heavyweight polypropylene mesh Intra‐abdominal mesh position: NR Surgical approach: laparoscopic |
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| Outcomes | Recurrence (follow‐up 2 years), pain, return to activity, local infection, seroma, haematoma, length of hospital stay, duration of surgery | |
| Notes |
Funding source(as originally reported) Not reported Declarations of interest for the primary investigators (as originally reported) Virinder Kumar Bansal and Vimi Rewari have no conflict of interest or financial ties to report Data for sensitivity analyses Randomised: 55/55 Analysed: 54/52 Imputed in ITT sensitivity analysis: 1/3 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation was done by using computer‐generated random numbers |
| Allocation concealment (selection bias) | Low risk | Sealed envelopes |
| 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 | No information on missing data and 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 |