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 |
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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 |
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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 |
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Outcomes | Postoperative stay: not defined; stated in methods and reported Complications and readmission: not validated; stated in methods and reported Final diagnosis: only reported |
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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 |