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 |
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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 |
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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 . |
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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 |
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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 |