Larsen 2001.
Methods | Randomised clinical trial. | |
Participants | Country: Denmark.
Number randomised: 50.
Mean age: 51 years.
Females: 35 (70%). Inclusion criteria:
Exclusion criteria:
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Interventions | Participants were randomly assigned to two groups: Group 1: abdominal wall lift (n = 24). Group 2: pneumoperitoneum with 12 mm Hg pressure (n = 26). Device used for abdominal lift: subcutaneous device. |
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Outcomes | The main outcome measures were complications, conversion to open cholecystectomy, and operating time. | |
Notes | One cross‐over from abdominal wall lift to control group because of poor visualisation. Attempts were made to contact the author in February 2007. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The allocation sequence was generated by random numbers". |
Allocation concealment (selection bias) | Unclear risk | Quote: "Patients were allocated randomly to the two groups by opening sealed envelopes on the day of operation." Comment: Further information was not available. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "The intervention assignments were concealed from the patients and the ward nursing staff." Comment: It was not clear whether the other healthcare providers were blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "The intervention assignments were concealed from the patients and the ward nursing staff." Comment: It was not clear whether the other healthcare providers were blinded. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: There were postrandomisation drop‐outs. |
Selective reporting (reporting bias) | High risk | Comment: Important outcomes were not reported. |
Vested interest bias | Unclear risk | Quote: "This study was supported by grants from Nordjyllands Amts Forskningsrád, Aalborgs Stifts Julelotteri and Det Obelske Familiefond." Comment: Not clear whether these were the only sources of support. |