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 |
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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 |
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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 |
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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 |
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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.