Brolin 1996.
Methods |
RCT Methods to control for contributory patient factors: none described |
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Participants |
Age: Group 1 (mean): 39 years Group 2 (mean): 38 years Gender: Group 1: 81.6% female Group 2: 80.0% female Type of incision: all participants had midline incisions Type of surgery: all were elective bariatric procedures Group 1: vertical banded gastroplasty: 9.2%; Roux‐en‐Y gastric bypass 90.8% Group 2: vertical banded gastroplasty: 11.7%; Roux‐en‐Y gastric bypass 88.3% Contamination classification of included participants: no information provided Pre‐operative antibiotic use: all participants received either a cephalosporin or vancomycin Prognostic patient factors: all participants were morbidly obese Inclusion criteria: participants who had gastric‐restrictive bariatric procedures performed by one surgeon, for treatment of morbid obesity Exclusion criteria: no exclusion criteria were explicitly reported |
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Interventions |
Comparisons reported: Group 1: Suture: polyester (multifilament, non‐absorbable) Suturing technique: continuous Closure method: layered (polyester on fascia, other layers closed by same methods in both groups) Group 2: Suture: PDS (monofilament, slowly absorbable) Suturing technique: interrupted, 'figure‐of‐eight' Closure method: layered (PDS on fascia) Characteristics of surgeons: all procedures were performed by a chief resident |
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Outcomes |
Incisional hernia: participant‐reported symptoms of discomfort or lumps in their incision Follow‐up duration: mean follow‐up was 29.4 months, 65% followed for > 2 years Wound infection: not defined Wound dehiscence: acute dehiscence on the first postoperative day |
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Notes | Minimum follow‐up period not described; hernias at 1 year not specifically addressed | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | "Randomization was carried out in the operating room according to the last digit of the patient's hospital identification number. Patients with an even number (n = 109) had closure with [Polyester]; patients with an odd digit (n = 120) had closure using [Polydioxanone]." |
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 | Low risk | All participants accounted for and included in the 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 |