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

Al‐Mulhim 2002.

Methods Design of RCT: parallel clinical trial                                                     
Power calculation: not stated                                                     
No blinding used                                                          
Follow‐up at four weeks                                                       
60 participants recruited, 60 randomly assigned                                                     
No data about participants excluded before random assignment                                                     
Lost to follow‐up: no data on number of participants seen at four weeks' follow‐up                                     
60 women analysed                                                     
Single centre: King Fahad Hospital, Hofuf, Al‐Hassa, Kingdom of Saudi Arabia     
Enrolment between January 1999 and April 2000                                                       
Source of funding: not provided        
Ethical issues: consent form obtained for each participant  
Method to establish definitive diagnosis: visual examination of appendix and abdominal cavity and histopathological examination of appendix in laparoscopic group. Not clearly stated but in all participants appendix removed and sent for histopathological study in conventional group
Participants Women with clinical diagnosis of acute appendicitis                                                      
Included: patients with clinical diagnosis of acute appendicitis, patients suitable for a right iliac fossa muscle‐splitting approach to the appendix, patients suitable for laparoscopy with no evidence of pregnancy                                        
No exclusion criteria stated                                                          
Mean age (SD): 23 years (14 to 35) in laparoscopy group, 26 years (14 to 42) in conventional group                                                    
Weight: 54 kg (30 to 82) in laparoscopy group, 58 kg (35 to 90) in conventional group                                                 
Mean serum white cell count: 12.8 (6.2 to 18.3) in laparoscopy group, 14.5 (8.2 to 19.6) in conventional group                
"Time of evolution of symptoms, median (range): 20 (6‐72) in laparoscopy group, 4 days (1‐80) in conventional group .
of the pain (SD): 22.1 (± 5) in laparoscopy group, 21.5 (± 3) in the conventional group"                                                         
Interventions Laparoscopic appendicectomy versus open appendicectomy                                                
Laparoscopic appendicectomy (group 1): three stab incisions required (a small midline incision was made at the umbilicus and a 10‐mm trocar was inserted, camera was inserted at this site); 5‐mm trocar below right costal margin and another five mm in the left iliac fossa of the abdomen placed under direct vision 
Open appendicectomy (group 2): carried out through a muscle‐splitting incisor in the right iliac fossa    
Surgeons participating in this study experienced in laparoscopic surgery; a Registrar with long general surgery experience usually performed open appendicectomy                                                     
Non‐inflamed appendix removed at both laparoscopic and open surgery, even when a definitive cause of the participant's symptoms was found. Postoperative pain control for both groups: pethidine 1 g/kg every six hours if needed for the first 24 hours, then shifted to intramuscular Voltaren 75 mg per request. Discharge pain medicine: paracetamol tablets                                                                                                
Outcomes Pathology findings: reported                                                     
"Operating time (minutes)": stated in methods and reported                                                      
Control of pain: number of doses of pethidine and Voltaren stated in methods and reported             
Mobilisation from bed: stated in methods and reported                                                 
Reintroduction of liquid and solid diet: stated in methods and reported                                                   
Return to normal activity: stated in methods and reported                                   
Complications: stated in methods and reported                                                                                                                
User defined 1  
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Text: states that participants were randomly assigned
Allocation concealment (selection bias) Unclear risk Text: states that a sealed envelope system was used
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. No loss to follow‐up reported
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 Low risk Baseline characteristics reported