Assalia 1993.
| Methods | Single‐centre randomised trial. Generation of allocation: unclear. Allocation concealment: unclear. Blinding: not performed. Follow‐up: unclear. Drop‐outs: none mentioned. Intention‐to‐treat: not mentioned. Sample size calculations: no. |
|
| Participants | Elective cholecystectomy for symptomatic cholelithiasis. In‐ and exclusion criteria: not mentioned. Comparability groups: well matched. |
|
| Interventions | SIC versus OC. Minicholecystectomy: initial 5 cm (no preoperative ultrasound location), extended in stages each 1 cm long. Retrograde (fundus down) technique was performed. Open cholecystectomy: technique was left to the individual surgeon. Length of incision: offer comfortable exposure, however, not too generous. Antibiotic prophylaxis: yes. Intra‐operative cholangiography: selectively carried out according to clinical and laboratory indications. |
|
| Outcomes | Primary and secondary outcome: not mentioned. Outcomes: difficulty of the procedure, operative time, degree of pain, total amount of analgesia, hospital stay, patient satisfaction, physical activity limitations. Duration of follow‐up: 2 weeks. |
|
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | Unclear risk | B ‐ Unclear |
| Blinding? All outcomes | High risk | |
| Free of selective reporting? | High risk | |
| Free of other bias? | High risk | short follow‐up of 2 weeks |