Hsiao 2000.
Methods |
RCT Methods to control for contributory patient factors: none |
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Participants |
Age: Group 1 (mean): 60.9 years Group 2 (mean): 58.5 years Gender: Group 1: 44% female Group 2: 48% female Type of incision: Group 1: midline 50.5%, paramedian 4.3%, subcostal 26.1%, subcostal plus midline 4.9%, bilateral subcostal plus midline 14.1% Group 2: midline 45.5%, paramedian 5.1%, subcostal 26.3%, subcostal plus midline 5.1%, bilateral subcostal plus midline 17.9% Type of surgery: all surgeries were elective Group 1: upper GI 17.4%, hepato‐pancreaticobiliary 63.6%, lower GI 15.2%, vascular 3.3%, other 0.5% Group 2: upper GI 15.4%, hepato‐pancreaticobiliary 65.4%, lower GI 13.5%, vascular 1.2%, other 4.5% Contamination classification of included participants: not described Pre‐operative antibiotic use: all participants received cefmetazole and metronidazole Prognostic patient factors: Group 1: mean BMI 23.0, malignancy 58.1% Group 2: mean BMI 22.8, malignancy 54.4% Inclusion criteria: patients undergoing elective laparotomy Exclusion criteria: emergency laparotomies, history of laparotomy within 3 months, previous incisional hernia |
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Interventions |
Comparisons reported: Group 1 Suture: polyglactin‐910 (multifilament, fast absorbable) Suturing technique: continuous Closure method: mass Group 2: Suture: PDS (monofilament, slowly absorbable) Suturing technique: continuous Closure method: mass Surgeon characteristics: same surgeon for all procedures |
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Outcomes |
Incisional hernia: visible and palpable defect in the fascia or a protrusion in the wound when the participant was carefully examined in both horizontal and vertical positions Follow‐up duration: 24 months Wound infection: purulent discharge from the wound, confirmed by standard signs including fever and an elevated leukocyte count Dehiscence: no definition provided 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) | High risk | Randomised based on last digit of hospital patient number |
Allocation concealment (selection bias) | High risk | Randomised based on last digit of hospital patient number |
Blinding (performance bias and detection bias) All outcomes | Low risk | Outcome assessor blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants accounted for and analysed |
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 |