Colak 2013.
Methods | Randomised controlled trial | |
Participants | Number of participants: 53 Number of centres: 1 Mean age: 29 years Number of males: 28 Number of females: 25 Inclusion criteria:diagnosis of acute appendicitis and admission to General Surgery Department of Samsun Education and Research Hospital between September 2010 and July 2011 Exclusion criteria: < 16 years of age, previous major abdominal operations, pregnancy, refusal to consent to participation in the study, and conversion to open appendectomy |
|
Interventions | Intervention arm: hem‐o‐lok (non‐absorbable polymeric clips) Control arm: ligature (Endoloop) Antibiotic use: prophylactic dose of third‐generation cephalosporin given intravenously after GA induction |
|
Outcomes | Primary outcome measures: intraoperative complications Secondary outcome measures: operative time and surgical findings |
|
Notes | Level of seniority of operating surgeon: The same surgical team (level of seniority not specified) performed all operations. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "patients randomly allocated" Comment: computer randomisation method used |
Allocation concealment (selection bias) | Low risk | Quote: "Randomization was conducted by using a computer‐generated randomisation schedule". Comment: probably done |
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 insufficent to allow judgement, but personnel would likely be aware from operative records. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Four participants excluded postoperatively owing to conversion to open appendectomy, and 3 participants owing to loss of 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. |