Ohira 2015.
Methods |
RCT Methods to control for contributory patient factors: unknown |
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Participants |
Age: not reported Gender: Group 1: female 7.1% Group 2: female 44.4% Types of incisions: all incisions were midline Types of surgery: all elective surgery Group 1: gastric 53.5%; colon 46.5% Group 2: gastric 55.6%; colon 44.4% Contamination classification of included participants: not reported Preoperative antibiotic use: not reported Prognostic patient factors: Group 1: diabetes 10.7%; average BMI 21.7 Group 2: diabetes 25.9%; average BMI 22.0 Inclusion criteria: gastric or colon cancer patients operated on with curative intent, aged 20‐80 years Exclusion criteria: non curative surgery, previous midline incision, laparoscopic surgery; immunosuppression (as defined by long‐term corticosteroid use, uncontrolled diabetes, or cirrhosis of the liver); and the surgeon’s judgment that the patient was unsuitable for the trial. |
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Interventions |
Comparisons reported: Group 1: Sutures: polyglactin (multifilament, fast absorbable) Suture technique: interrupted Closure method: mass closure Group 2: Sutures: PDS (monofilament, slowly absorbable) Suture technique: interrupted Closure method: mass closure |
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Outcomes |
Hernia: physical exam, CT scan every 6 months; follow‐up: up to 36 months (minimum 12 months) Wound Infection: not defined Dehiscence: not defined |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation sequence not clearly described |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not clearly described |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Blinding of outcome assessors not clearly stated |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants accounted for |
Selective reporting (reporting bias) | Low risk | There was no evidence of selective reporting |
Other bias | High risk | Participants not similar at baseline (higher proportion of women in group 2, 2 vs 12); curative intent of surgery not determined until after randomisation |