Bloemen 2011.
Methods |
RCT Methods to control for contributory patient factors: none described |
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Participants |
Age: Group 1 (mean): 63.1 years Group 2 (mean): 63.8 years Gender: Group 1: 40.6% female Group 2: 44.9% female Type of incision: all participants received midline incisions Type of surgery: Group 1: elective 80.1%; colorectal cancer 47.7%, aortic aneurysm 11.3%, benign colorectal 13.3%, gastric cancer 3.5%, cholelithiasis 5.5%, bowel perforation 3.9%, hiatal hernia 3.9%, appendicitis 2.0%, other 9.0% Group 2: elective 85.4%; colorectal cancer 53.2%, aortic aneurysm 10.9%, benign colorectal 12.3%, gastric cancer 4.9%, cholelithiasis 2.6%, bowel perforation 3.4%, hiatal hernia 2.6%, appendicitis 3.0%, other 7.1% Contamination classification of included participants: not described Pre‐operative antibiotic use: not described Prognostic patient factors: Group 1: DM 9.8%; mean BMI 25.6; steroids 6.3%; chronic pulmonary conditions 3.9% Group 2: DM 6.4%; mean BMI 25.8; steroids 7.9%; chronic pulmonary conditions 10.1% Inclusion criteria: elective or emergent laparotomy with midline incision Exclusion criteria: pregnancy, presence of an abdominal hernia, lack of informed consent, age < 18 years or life expectancy of < 1 year |
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Interventions | Group 1:
Suture: 1‐0 polypropylene (monofilament, non‐absorbable)
Suturing technique: continuous
Closure method: mass
Group 2:
Suture: 1‐0 PDS (monofilament, slowly absorbable)
Suturing technique: continuous
Closure method: mass Surgeon characteristics: consultant or resident surgeons |
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Outcomes |
Incisional hernia: defined as "any abdominal wall gap with or without a bulge in the area of a postoperative scar, perceptible or palpable by clinical examination or imaging" Follow‐up duration: up to 54 months Dehiscence: "Early post‐operative fascial dehiscence was distinguished from later incisional hernia, defined by a clinically palpable gap in the abdominal fascia with, or without wound dehiscence during the first 30 days after surgery..." Wound infection: not defined Sinus or fistula: not defined |
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Notes | Occurrence of incisional hernia at 1 year used in analysis | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation |
Allocation concealment (selection bias) | Low risk | Sealed, opaque envelopes |
Blinding (performance bias and detection bias) All outcomes | Low risk | Outcome assessors blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants accounted for and included in analysis |
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 |