Leaper 1977.
Methods |
RCT Methods to control for contributory patient factors: none |
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Participants |
Age: not stated Gender: Group 1 female 54.3% Group 2 female 53% Group 3 female 46.7% Types of incisions: Group 1 paramedian 11.2%, midline 56.9%, transverse 31.9% Group 2 paramedian 10.7%, midline 53.7%, transverse 35.5% Group 3 paramedian 10%, midline 54.1%, transverse 35.8% Types of surgery: Group 1 colorectal 26.7%, biliary 20.7%, gastric 28.4%, miscellaneous 24.1% Group 2 colorectal 26.4%, biliary 28.9%, gastric 22.3%, miscellaneous 22.3% Group 3 colorectal 27.5%, biliary 25.8%, gastric 34.2%, miscellaneous 12.5% Contamination classification of included participants: Preoperative antibiotic use: Prognostic patient factors: Malignancy: Group 1 25.8%, Group 2 34.7%, Group 3 36.7% COPD: Group 1 44%, Group 2 52%, Group 3 42% Hypoproteinaemia: Group 1 11%, Group 2 10%, Group 3 5% Inclusion criteria: major laparotomies Exclusion criteria: appendectomy through muscle‐splitting incision, lumbar sympathectomy, renal bladder and prostatic surgery, incisions through previous scars |
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Interventions |
Comparisons reported: Group 1: Sutures: nylon (monofilament, non‐absorbable) Suture technique: continuous Closure method: layered (peritoneum and posterior sheath closed with chromic catgut, anterior sheath by nylon) Group 2: Sutures: PGA (multifilament, fast absorbable) Suture technique: interrupted (Smead Jones) Closure method: mass closure Group 3: Sutures: steel (monofilament, non‐absorbable) Suture technique: interrupted (Smead Jones) Closure method: mass closure Characteristics of surgeons: Consultant: Group 1 25.8%, Group 2 28.9%, Group 3 30% |
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Outcomes |
Hernia: bulge noticeable by patient and assessor upon standing Follow‐up duration: 6 months Wound infection: primary sepsis is discharge of pus from a previously dry wound, secondary sepsis is acquisition of infection by a discharging wound. Major sepsis involves the deep layers of the wound and is accompanied by constitutional symptoms Dehiscence: separation of deep layers, heralded by discharge of ascites Sinus or fistula: not defined |
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Notes | Hernia data excluded from analysis due to inadequate follow‐up duration Group 2 compared with group 3 for 'absorbable versus non‐absorbable' and 'monofilament versus multifilament' as they share a common closure technique and method Group 2 and 3 analysed together as 'interrupted', 'mass' |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation was by "means of instructions in a sealed envelope" |
Allocation concealment (selection bias) | Low risk | Sealed envelope |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not described |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants accounted for and analysed |
Selective reporting (reporting bias) | Low risk | There was no evidence of selective reporting |
Other bias | High risk | Surgeons refused randomisation in 17 cases |