Navarra 2002.

Methods	Design of RCT: parallel clinical trial                                                   Power calculation: not stated                                                  No blinding used                                                         Follow‐up: not stated                                                              148 participants recruited, 148 randomly assigned                                                        No participants refused to enter the trial                                                           Lost to follow‐up: 12 participants in laparoscopy group and 15 participants in conventional group                                                    148 participants analysed                                                  Single centre: l'Istituto di Clinica Chirurgica Generale e Terapia Chirurgica del l'Universita di Ferrara                            Enrolment between October 1993 and December 1998                                                   Source of funding: not stated   Ethical issues: not stated  Method used to establish definitive diagnosis: visual examination of appendix and abdominal cavity in laparoscopic group. Not clearly stated in conventional group
Participants	Women with suspected clinical diagnosis of appendicitis         Exclusion criteria: not stated                                                   Median age in laparoscopy group: 26.3 years (15 to 77). Median age in conventional group: 29.6 years (15 to 75)
Interventions	Laparoscopic appendicectomy versus open appendicectomy (conventional)                   Laparoscopy performed with participant in lithotomy modified position. Verres needle inserted into umbilical area, followed by a a 10‐mm port for placement of the video camera. Complete review of the abdominal cavity performed to confirm the clinical diagnosis or to determine associated cause of the pain. If peritoneal liquid was found, sample of peritoneal liquid was taken. When no abnormality was identified at laparoscopy, appendicectomy was performed Conventional method: McBurney incision performed in open appendicectomy
Outcomes	Duration of procedure: stated in methods and reported                                        Postoperative pain: stated in methods and reported                                                   Duration of hospital stay: stated in methods and reported                                     Intraoperative and postoperative complications: stated in methods and reported                                             Histopathological diagnosis: stated in methods and reported
User defined 1
Notes	A not clearly defined group of the recruited women: older than 50 years
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomly assigned by using a randomisation list
Allocation concealment (selection bias)	Unclear risk	No further description provided
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. 12 participants in the laparoscopy group and 15 participants in the control group were 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	Unclear risk	Index test incorporated as the reference standard in the laparoscopic group
Other bias	Unclear risk	Not all baseline characteristics reported