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

van Dalen 2003.

Methods Randomisation by closed envelope system                                                    
Design of RCT: parallel clinical trial                                                   
Power calculation: not stated                                                 
No blinding used                                                        
"Time of follow up: only in patients in whom an appendectomy was not performed was undertaken in September 2001"                                                  
63 women of 163 participants with appendicitis diagnosis
No participants excluded after random assignment                                                     
Participants lost to follow‐up: not clearly stated                                                   
60 women analysed                                                  
Single centre: Department of Surgery, Christchurch Hospital, Christchurch, New Zealand                                                
Enrolment from July 1991 to July 1992                                                 
Source of funding: not stated
Ethical issues: ethical approval obtained from the Canterbury Ethics Committee 
Method used to establish definitive diagnosis: visual examination of appendix and abdominal cavity and histopathological examination of appendix when removed in laparoscopic group. Not clearly stated in conventional group, but in all participants, appendix removed and sent for histopathological study
Participants "Female patients aged between 16 and 45 years with a clinical diagnosis of acute appendicitis were eligible for inclusion in the study. Suitable patients in whom a decision had been made to proceed to appendectomy were asked to participate in the study. They were excluded if informed consent was not obtained, or if laparoscopy was contraindicated"                                                         
Mean age (range): 24 years (16 to 45) in laparoscopy group, 22 years (16 to 51) in conventional group                                               
Mean temperature (range): 37.3 °C (36 to 38.4) in laparoscopy group, 37 °C (35.2 to 39.5) in conventional group                              
Mean serum white cell count (range): 13,000 (4200 to 21,500) in laparoscopy group, 13,100 (7100 to 22,000) in conventional group                                                    
Duration of pain (range): 35.5 days (five to 120) in laparoscopy group and 43.3 days (six to 168) in conventional  group                                              
Interventions Laparoscopy first or open appendicectomy performed directly                                                    
If appendix clearly seen and looking normal, no appendicectomy carried out. If other pathology seen, this was dealt with appropriately. If inflamed appendix seen or evidence thereof, or if appendix could not be seen, open appendicectomy carried out                                                           
Those assigned to appendicectomy group: routine open appendicectomy and other pathology dealt with as necessary 
Outcomes Mean operating time: not defined or stated in methods, only reported                          
Total days of stay: not defined or stated in methods, only reported                                                           
Median postoperative stay: not defined or stated in methods, only reported                                                    
Diagnostic accuracy: not defined or stated in methods, only reported      
User defined 1  
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Only mentioned the word "randomised". No further description provided
Allocation concealment (selection bias) Unclear risk Publication: states that sealed envelopes were 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. Three of 63 lost to follow‐up
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 High risk Index test incorporated as the reference standard in the laparoscopic group
Other bias Unclear risk All baseline characteristics not reported

Abbreviations

CT = computed tomography.

GSRS = Gastrointestinal Symptom Rating Scale.

IUD = intrauterine device.

NSAP = non‐specific abdominal pain.

NSLAP = non‐specific lower abdominal pain.

PGWB = Psychological General Well Being Index.

PID = pelvic inflammatory disease.

RCT = randomized controlled trial.

SD = standard deviation.

STD = sexually transmitted disease.

US = ultrasonography.