Leaper 1985.
Methods |
RCT Methods to control for contributory patient factors: |
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Participants |
Age (SD): Group 1 mean 57.4 years (1.8), Group 2 mean 57.9 years (1.7) Gender: Group 1 female 64%, Group 2 female 60% Types of incisions: Group 1: midline 77.3%, transverse 22.7% Group 2: midline 72%, transverse 28% Types of surgery: Group 1: oesophageal 14.4%, pancreaticobiliary 49.5%, small bowel 4.1%, colon 23.7%, unopened viscus 8.2% Group 2: oesophageal 17.7%, pancreaticobiliary 41.1%, small bowel 4.7%, colon 27.1%, unopened viscus 9.3% Contamination classification of included participants: Preoperative antibiotic use: single intravenous dose of third generation cephalosporin at induction for oesophago‐duodeno‐gastric, biliary and pancreatic operations; either the same or a combination with metronidazole at induction and at 6 and 12 h postoperatively for small bowel and colorectal operations Prognostic patient factors: Malignancy: Group 1 25.8%, Group 2 29% Jaundice: Group 1 25.8%, Group 2 16.3% Inclusion criteria: midline and transverse incisions Exclusion criteria: incisions through scar |
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Interventions |
Comparisons reported: Group 1: Sutures: nylon (monofilament, non‐absorbable) Suture technique: continuous Closure method: mass Group 2: Sutures: PDS (monofilament, slowly absorbable) Suture technique: continuous Closure method: mass Characteristics of surgeons: Group 1 consultants 33%, Group 2 consultants 37.4% |
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Outcomes |
Hernia: not defined Follow‐up duration: 6 months Wound infection: not defined Dehiscence: not defined |
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Notes | Hernia data excluded due to inadequate follow‐up duration | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated |
Allocation concealment (selection bias) | Unclear risk | Not explicitly described |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not explicitly described |
Incomplete outcome data (attrition bias) All outcomes | High risk | Not an intention‐to‐treat analysis |
Selective reporting (reporting bias) | Low risk | There was no evidence of selective reporting |
Other bias | Low risk | The study appears to be free of other sources of bias |