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. 2014 May 22;2014(5):CD007683. doi: 10.1002/14651858.CD007683.pub3

Olsen 1993.

Methods Design of RCT: parallel‐group clinical trial                                                   
Power calculation: not stated                                                 
No blinding used                                                        
Time of follow‐up: not stated                                                 
60 women among 151 patients with diagnosis of appendicitis. 91 not included because of exclusion criteria or because a surgeon with laparoscopic skills was not available                                                   
No participants excluded after random assignment                                                     
Participants lost to follow‐up: not clearly stated                                                   
60 women analysed                                                  
Single centre: Department of Surgery, Kolding County Hospital, Kolding, Denmark                                                
Enrollment from 1 January 1988 to 26 November 1991      
Source of funding: not stated
Ethical issues: approved by the local ethics committee
Method to establish definitive diagnosis: visual examination of appendix in laparoscopic group. Not clearly stated in conventional group
Participants "Women aged 15‐56 years with clinical signs of acute appendicitis were studied"                                                    
Participants with signs of diffuse peritonitis, with a previous diagnosis of diffuse peritonitis and with more than two previous lower laparotomies excluded                              
Mean age (range), years: 25.3 (15 to 54) in laparoscopy group, 25.8 (15 to 56) in direct operation 
Interventions Laparoscopy versus direct operation                                       
Appendicectomy performed through a transverse incision in the right iliac fossa
Laparoscopy performed under general anaesthesia: no other data provided                                                 
Appendicectomy performed when acute appendicitis was confirmed and when a diagnosis of appendicitis could not be excluded                                              
Appendicitis excluded if a normal appendix could be seen throughout its length. If other abnormalities were found, appropriate treatment given                    
Outcomes Postoperative stay: not defined; stated in methods and reported
Complications and readmission: not validated; stated in methods and reported
Final diagnosis: only reported  
User defined 1  
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Text: trial performed in a randomised fashion. No other description provided about how randomisation was generated
Allocation concealment (selection bias) Unclear risk Text: nothing stated about how concealment was achieved 
Blinding (performance bias and detection bias) 
 All outcomes High risk Open RCT
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Not clear whether follow‐up was similar in the two groups. All randomly assigned participants analysed
Selective reporting (reporting bias) Unclear risk Protocol of the study not available
Free of differential verification bias Unclear risk Definitive diagnosis not done with the same reference standard in both groups
Free of partial verification bias Unclear risk Non‐random set of participants not undergoing the reference standard
Free of Incorporation Bias High risk Index test incorporated as the reference standard in the laparoscopic group
Other bias Unclear risk All baseline characteristics not reported