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

Bruwer 2003.

Methods Design of RCT: parallel clinical trial                                                     
Power calculation: not stated                                                    
No blinding used                                                          
Time of follow‐up: four weeks, by phone or personal interview                                      
34 women of 81 participants with appendicitis diagnosis; 47 not included because of exclusion criteria (41) or because a surgeon with laparoscopic skills was not available (4). No consent form given (2)                                                        
No participants excluded after random assignment                                                         
Participants lost to follow‐up: not clearly stated                                                       
34 women analysed
Single centre: Department of Surgery, Tygeberg Hospital and University of Stellenbosch, South Africa                                 
Enrolment from April 1997 to March 2001                                                     
Source of funding: not stated       
Ethical issues: protocol approved by the Research Committee of the University of Stellenbosch. Signed consent form used
Method to establish definitive diagnosis: visual examination of appendix in abdominal cavity (except in cases with McBurney or Lanz incision) and pathology when appendicectomy was performed                                 
Participants Women 15 to 45 years of age in whom appendicitis diagnosis was not associated with clinical signs of acute appendicitis and could not be excluded on clinical and ancillary grounds. Independent decision made that surgical exploration was necessary; informed consent given                                                         
Exclusion criteria: compromised immune status, positive pregnancy test, major anaesthetic risk as a result of a systemic disease. Evidence of systemic sepsis or complicated appendicitis (peritonitis, or right iliac fossa mass)                                                        
Mean age: not informed
Mean temperature: not reported                                                   
Mean serum white cell count: not reported                                                         
Mean days of abdominal pain: not reported                       
Interventions Open versus laparoscopic exploration                                                 
Laparoscopic appendicectomy employed a three‐port technique. Initial subumbilical port (camera) placed following open access to the peritoneal cavity. Additional ports 5 mm suprapubically and 10 mm in the left iliac fossa 
Open surgical exploration via right iliac fossa or via abdominal midline incision at the discretion of the operating surgeon. Appendicectomy, if required, performed using conventional techniques. Appendix left intact if alternative pathology was found, except in participants undergoing exploration via McBurney or Lanz incision
At least one of the study authors was present as surgeon or assistant during all procedures    
Appendicectomy performed when acute appendicitis was confirmed and when another pathology was not found to account for clinical presentation  .                                                 
Outcomes Operating time: defined as time from complete anaesthetic induction to skin closure; stated in methods and reported                                                 
Postoperative stay: calculated as one night for each midnight spent in the hospital; stated in methods and reported                                                   
Number of analgesic doses in each participant and analgesic days: stated in methods and reported                                                    
Return to normal activities reported in days: stated in methods and reported                                                      
Return to work: stated in methods and reported     
Adverse events: not clearly validated        
User defined 1  
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Envelope sequence prepared by uninvolved person from a computer‐generated randomisation list
Allocation concealment (selection bias) Low risk Treatment assigned by opening the next in a series of sequentially numbered envelopes containing instructions for open or laparoscopic appendicectomy
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 the two groups
Free of partial verification bias Unclear risk Non‐random set of participants not undergoing the reference standard
Free of Incorporation Bias Unclear risk Index test incorporated as the reference standard in the laparoscopic group
Other bias Unclear risk Baseline characteristics not reported