Al‐Mulhim 2002.
Methods | Design of RCT: parallel clinical trial Power calculation: not stated No blinding used Follow‐up at four weeks 60 participants recruited, 60 randomly assigned No data about participants excluded before random assignment Lost to follow‐up: no data on number of participants seen at four weeks' follow‐up 60 women analysed Single centre: King Fahad Hospital, Hofuf, Al‐Hassa, Kingdom of Saudi Arabia Enrolment between January 1999 and April 2000 Source of funding: not provided Ethical issues: consent form obtained for each participant Method to establish definitive diagnosis: visual examination of appendix and abdominal cavity and histopathological examination of appendix in laparoscopic group. Not clearly stated but in all participants appendix removed and sent for histopathological study in conventional group |
|
Participants | Women with clinical diagnosis of acute appendicitis Included: patients with clinical diagnosis of acute appendicitis, patients suitable for a right iliac fossa muscle‐splitting approach to the appendix, patients suitable for laparoscopy with no evidence of pregnancy No exclusion criteria stated Mean age (SD): 23 years (14 to 35) in laparoscopy group, 26 years (14 to 42) in conventional group Weight: 54 kg (30 to 82) in laparoscopy group, 58 kg (35 to 90) in conventional group Mean serum white cell count: 12.8 (6.2 to 18.3) in laparoscopy group, 14.5 (8.2 to 19.6) in conventional group "Time of evolution of symptoms, median (range): 20 (6‐72) in laparoscopy group, 4 days (1‐80) in conventional group . of the pain (SD): 22.1 (± 5) in laparoscopy group, 21.5 (± 3) in the conventional group" |
|
Interventions | Laparoscopic appendicectomy versus open appendicectomy Laparoscopic appendicectomy (group 1): three stab incisions required (a small midline incision was made at the umbilicus and a 10‐mm trocar was inserted, camera was inserted at this site); 5‐mm trocar below right costal margin and another five mm in the left iliac fossa of the abdomen placed under direct vision Open appendicectomy (group 2): carried out through a muscle‐splitting incisor in the right iliac fossa Surgeons participating in this study experienced in laparoscopic surgery; a Registrar with long general surgery experience usually performed open appendicectomy Non‐inflamed appendix removed at both laparoscopic and open surgery, even when a definitive cause of the participant's symptoms was found. Postoperative pain control for both groups: pethidine 1 g/kg every six hours if needed for the first 24 hours, then shifted to intramuscular Voltaren 75 mg per request. Discharge pain medicine: paracetamol tablets |
|
Outcomes | Pathology findings: reported "Operating time (minutes)": stated in methods and reported Control of pain: number of doses of pethidine and Voltaren stated in methods and reported Mobilisation from bed: stated in methods and reported Reintroduction of liquid and solid diet: stated in methods and reported Return to normal activity: stated in methods and reported Complications: stated in methods and reported |
|
User defined 1 | ||
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Text: states that participants were randomly assigned |
Allocation concealment (selection bias) | Unclear risk | Text: states that a sealed envelope system was 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. No loss to follow‐up reported |
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 | Low risk | Baseline characteristics reported |