Nadeem 2015.
Methods | Randomised controlled trial | |
Participants | Number of participants: 68 Number of centres: 3 Mean age: 24 years Number of males: 37 Number of females: 31 Inclusion criteria: undergoing laparoscopic appendectomy in 3 tertiary care hospitals in Peshawar from 1 June 2013 to 1 June 2014 Exclusion criteria: perforation of appendix, local and diffuse peritonitis, friable appendix base, evidence of pelvic inflammatory disease, conversion to open procedure, and possible other diagnoses |
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Interventions | Intervention arm: metallic endoclip Control arm: extracorporeal ligature tie Antibiotic use: oral cefixime for 5 to 7 days |
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Outcomes | Primary outcome measures: bleeding, organ injury, postoperative ileus, intra‐abdominal infection, surgical site infection, re‐admission, and reoperation Secondary outcome measures: cost, operative time, and hospital stay |
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Notes | Level of seniority of operating surgeon: All participants underwent minimal access surgery performed by certified surgeons with more than 10 years' experience in laparoscopic procedures. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomised controlled trial" |
Allocation concealment (selection bias) | Unclear risk | Quote: "were divided randomly into two groups" Comment: no information on allocation method available to allow judgement |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "single‐blinded" Comment: This is a drawback of these types of trials, as it is impossible to blind surgeons to the procedure; however, single‐blinded suggests that participants were not aware of the method used. Personnel would likely be aware from operative records. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The residents/intern present at the time of procedure would collect the data on data sheets with no blinded investigators who could collect data and at the same time be blinded for the type of procedure done". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No participants were lost to follow‐up. |
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. |