Schmitz 1997.
Methods | Prospective randomised study with 64 participants included, comparing mesh and non‐mesh inguinal hernia repairs | |
Participants | All 94 participants with primary inguinal hernia were operated on, of which, according to statistical calculations and inclusion criteria, 64 were included in the study. Inclusion criteria Male and female, age: 17‐75 years, informed consent (comment: participants were told about both surgical methods), primary hernia. Exclusion criteria Acute incarceration, immune suppression, coagulation disorders, relapse, hepatosis, diabetes mellitus, malignant tumour |
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Interventions |
Group A Tension‐free surgical treatment (n = 32) Group B Shouldice herniorrhaphy (n = 32): as per the original publication All participants were operated on with endotracheal anaesthesia. Four surgeons with long lasting Shouldice operation experience took part in the study. Mean operation duration was 43 ± 10 min in Shouldice group and 31 ± 7.5 in TF‐group |
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Outcomes | Surgical early complications (including hematomas, infections, seromas and testicular swelling) and wound healing were assessed till the day of discharge on the 6th postoperative day. Postoperative pain was assessed using a VAS and quantifying the amount of paracetamol taken by individual participants. | |
Notes | A 2 day earlier release of pain was suspected using TF‐method in comparison to Shouldice method, so a population size of n = 32 participants/group was calculated using t‐tests for unpaired samples for comparison of means (assumed standard deviation: 2 days) to calculate a level of significance P < 0.05 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised by 'letter' (no details described, not described if envelopes were used) immediately before operation |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not mentioned |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not mentioned |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Classification of hernia type and wound status postoperative (hematoma, infections, seroma, testicle swelling) is reported for all 64 participants. No attrition reported. |
Selective reporting (reporting bias) | Low risk | Different categories of wound status (hematoma, infections, seroma, testicle swelling) are reported for the period of day 1‐6. Acetaminophen use and pain on lying, walking and sitting up were reported as diagrams, no exact numbers reported (picture 1‐4) |
Other bias | Low risk | No other sources of bias found |