Larsen 2004.
Methods | Randomised clinical trial. | |
Participants | Country: Denmark.
Number randomised: 50.
Mean age: 49 years.
Females: 18 (36%). Inclusion criteria:
Exclusion criteria:
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Interventions | Participants were randomly assigned to two groups: Group 1: abdominal wall lift (n = 22). Group 2: pneumoperitoneum with 12 mm Hg pressure (n = 28). Device used for abdominal lift: subcutaneous device. |
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Outcomes | The main outcome measure was operating time. | |
Notes | Withdrawal = 4 because of technical problems with recording echocardiography (in this trial, echocardiographic changes were compared between the groups). 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 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 unknown to the patients and the 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 unknown to the patients and the 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) | Low risk | Comment: All important outcomes were reported. |
Vested interest bias | Unclear risk | Quote: "This study was supported by funding from Nordjyllands Amts Forskningsraad, Aalborg Stifts Julelotteri and Det Obelske Familefond." Comment: Not clear whether these were the only sources of support. |