Shalaby 2001.
Methods | Randomised controlled trial | |
Participants | Number of participants: 150 Number of centres: 2 Mean age: 10 years Number of males: 67 Number of females: 83 Inclusion criteria: diagnosis of acute appendicitis from October 1997 to October 1999 Exclusion criteria: NS |
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Interventions | Intervention arm 1: Endo GIA (Ethicon Endo‐Surgery, Cincinnati, Ohio, USA) stapler Intervention arm 2: extracorporeal laparoscopically assisted appendectomy Control arm: ligature (Endoloop) Antibiotic use: 50 mg/kg ceftriaxone preoperatively, then 1 or 2 doses postoperatively. Metronidazole 25 mg/kg to those with suppurative and gangrenous appendicitis |
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Outcomes | Primary outcome measures: residual abscess, wound infection, bleeding, and intestinal obstruction Secondary outcome measures: cost, operative time, and hospital stay |
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Notes | Level of seniority of operating surgeon not specified | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomly assigned to one of the groups using a table of random numbers. The randomisation procedure was not restricted". |
Allocation concealment (selection bias) | Unclear risk | Information insufficient to allow judgement |
Blinding of participants and personnel (performance bias) All outcomes | High risk | It is unclear whether participants were aware of the method used. Personnel would likely be aware from operative records. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Information insufficient to allow judgement, but personnel would likely be aware from operative records. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data |
Selective reporting (reporting bias) | Unclear risk | No a priori publication of intended outcomes was identified from either a published trial protocol or trial registration. |
Other bias | Low risk | This study appears to be free of other sources of bias. |