Colombo 1997.
Methods |
RCT Methods to control for contributory patient factors: none described |
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Participants |
Age: Group 1 (mean): 51.1 years Group 2 (mean): 52.7 years Gender: all participants were female Type of incision: Group 1: lower midline 75%, complete midline 25% Group 2: lower midline 79%, complete midline 21% Type of surgery: Group 1: exploratory laparotomy 51.0%, exploratory laparotomy with bowel resection and anastomosis 13.3%, radical hysterectomy with pelvic lymphadenectomy 23.4%, total hysterectomy 10.1%, pelvic exenteration 2.3% Group 2: exploratory laparotomy 52.6%; exploratory laparotomy with bowel resection and anastomosis 11.1%; radical hysterectomy with pelvic lymphadenectomy 20.3%; total hysterectomy 15.0%; pelvic exenteration 1.0% Contamination classification of included participants: no information provided Pre‐operative antibiotic use: all participants in both groups received pre‐operative antibiotics: 1‐2 doses of intravenous cefazolin for procedures with no bowel resection and cefoxitin, gentamicin and metronidazole for procedures involving bowel resection Prognostic patient factors: all participants in both groups had malignancy Group 1: diabetes 2%, obesity (BMI ≥ 25 kg/m2) 30%, prior chemotherapy 38%, prior radiotherapy 5% Group 2: diabetes 3%, obesity (BMI ≥ 25 kg/m2) 32%, prior chemotherapy 32%, prior radiotherapy 6% Inclusion criteria: all women admitted for surgical treatment of gynaecological cancer using a vertical midline incision Exclusion criteria: none described |
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Interventions |
Comparisons reported: Group 1 Suture: polyglyconate (multifilament, slowly absorbable) Suturing technique: continuous Closure method: mass Group 2: Suture: PGA (multifilament, fast absorbable) Suturing technique: interrupted Closure method: mass Surgeon characteristics: "Most wounds were closed by house officers under the direct supervision of a senior staff gynaecologist..." |
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Outcomes |
Incisional hernia: any palpable defect in the fascia, even if an increase in intra‐abdominal pressure did not result in a swelling in the abdominal scar Follow‐up duration: 12, 24 and 36 months Wound infection: purulent discharge with or without a positive culture Wound dehiscence: no definition provided Suture sinus or fistula: no definition provided |
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Notes | Hernia data at 12 months used in analysis | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "...according to a table of computer‐generated random numbers..." |
Allocation concealment (selection bias) | Low risk | "At the moment of abdominal‐wall suturing, a nurse assigned the patients to one of two closure techniques according to a table of computer‐generated random numbers and informed the surgeons of the type of closure to be used." |
Blinding (performance bias and detection bias) All outcomes | Low risk | "Incisions were evaluated using careful palpation by physicians who were unaware of the type of suturing technique." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants included in analysis. Excluded participants discussed (met exclusion criteria) |
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 |