Gys 1989.
Methods |
RCT Methods to control for contributory patient factors: none |
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Participants |
Age: Group 1 (mean): 64 years Group 2 (mean): 61 years Gender: Group 1: 48% female Group 2: 49% female Type of incision: Group 1: upper midline 30%, lower midline 39%, full midline 9%, subcostal 25%, other 7% Group 2: upper midline 30%, lower midline 34%, full midline 9%, subcostal 27%, other 0% Type of surgery: Group 1: emergency 24%; colorectal 34%, pancreaticobiliary 28%, oesophagogastric 22%, vascular 6%, other 10% Group 2: emergency 26%; colorectal 32%, pancreaticobiliary 34%, oesophagogastric 20%, vascular 3%, other 11% Contamination classification of included participants: Group 1: contaminated 9.0% Group 2: contaminated 4.6% Pre‐operative antibiotic use: not described Prognostic patient factors: Group 1: diabetes 9.0%, obesity 40.3%, malignancy 56.7%, respiratory failure 9.0%, jaundice 4.5% Group 2: diabetes 7.7%, obesity 30.8%, malignancy 44.6%, respiratory failure 9.2%, jaundice 7.7% Inclusion criteria: consecutive patients undergoing elective or emergency laparotomy Exclusion criteria: none described |
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Interventions |
Comparisons reported: Group 1 Suture: nylon (monofilament, non‐absorbable) Suturing technique: continuous Closure method: layered ('0' for peritoneum, '1' for musculo‐aponeurotic layer) Group 2: Suture: polyglyconate (monofilament, slowly absorbable) Suturing technique: continuous Closure method: layered ('0' for peritoneum, '1' for musculo‐aponeurotic layer) Surgeon characteristics: not described |
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Outcomes |
Incisional hernia: assessed by palpation with patient lying supine and with elevation of extended legs Follow‐up duration: 1 year Wound infection: postoperative purulent discharge with proven growth of a micro‐organism Dehiscence: "burst abdomen" Sinus or fistula: no definition provided |
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Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not described |
Incomplete outcome data (attrition bias) All outcomes | High risk | Of the total of 132 participants, 13 (9.8%) died within 1 year and 22 (17.0%) were lost to follow‐up |
Selective reporting (reporting bias) | Low risk | Hernia (at least 1 year); dehiscence and wound infection outcomes all reported |
Other bias | Low risk | The study appears to be free of other sources of bias |