Schmitz 1997.
Methods | Randomised clinical single‐centre trial. Generation of allocation: unclear. Allocation concealment: adequate. Blinding: not performed. Follow‐up: adequate. Drop‐outs: none; postoperative observation was extended to complete the investigation. Intention‐to‐treat: not mentioned. Sample size calculations: no. |
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Participants | Patients for elective cholecystectomy. In‐ and exclusion criteria: not very well described. Comparability groups: well matched. |
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Interventions | SIC versus OC. SIC: 6 cm subcostal transverse incision with diathermy transsection of the right rectus abdominis muscle. OC: a 13 cm subcostal incision with additional partial extension into the muscle spaces of the right lateral epigastric region. Antibiotic prophylaxis: not mentioned. Intra‐operative cholangiography: not mentioned. |
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Outcomes | Primary and secondary outcome: not mentioned. Outcome measures: operating times, level of subjective pain, analgesic intake, complications. Duration of follow‐up: not mentioned. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |
Blinding? All outcomes | High risk | |
Incomplete outcome data addressed? All outcomes | Low risk | |
Free of selective reporting? | High risk | |
Free of other bias? | High risk | unclear duration of follow‐up |