Langenbach 2020.
Study characteristics | ||
Methods | Randomised controlled trial Location Department of Surgery, Helios St. Elisabeth Klinik Oberhausen, Germany Study dates Between January 2016 until January 2018 |
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Participants |
Inclusion criteria Abdominal wall hernia needing open surgery, written informed consent, no co‐existing chronic diseases with permanent use of analgesics, no neuro‐muscular diseases with chronic pain sensation, no emergency operations or other simultaneous interventions, no pregnancy or patients with previous IPOM procedure Patient characteristics (absorbable tacks (28) / absorbable sutures (20)) Age (mean, SD): 62.2 (15.3), 61.4 (12.8) Gender (male, %): 11 (39%) / 8 (40%) BMI (kg/m2, mean, range): 34.0 (6.6) / 31.2 (6.3) Hernia type (incisional, %): 20 (71%) / 17 (85%) Hernia size (median, range): 33 (4 – 204) / 46 (4 – 616) Comorbidity:
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Interventions | Intervention/control: absorbable tacks (2 cm distance) compared to absorbable sutures (2 cm distance) Mesh: composite mesh Intra‐abdominal mesh position: IPOM Surgical approach: open |
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Outcomes | Recurrence (1 year), pain (primary outcome), HRQOL, return to activity, postoperative complications, duration of surgery | |
Notes |
Funding source(as originally reported) Not reported. Declarations of interest for the primary investigators (as originally reported) There is no conflict of interests Data for sensitivity analyses Randomised: 28/20 Analysed: not reported Imputed in ITT sensitivity analysis: not applicable |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random list |
Allocation concealment (selection bias) | Low risk | Group allocations were stored in sequentially‐numbered opaque, 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 | Low risk | No dropouts |
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 |