Unbehaum 1995.
Methods | Randomised clinical trial. | |
Participants | Country: Germany.
Number randomly assigned: 71.
Postrandomisation dropouts: 10 (14.1%).
Revised sample size: 61. Mean age: 47 years. Females: 44 (72.1%). Inclusion criteria: 1. Elective laparoscopic cholecystectomy. 2. Symptomatic gall stones. Exclusion criteria: 1. Conversion to open cholecystectomy. 2. Requirement for other procedures. |
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Interventions | Participants were randomly assigned to different pressures of pneumoperitoneum. Group 1: low pressure 8 to 10 mm Hg (n = 30). Group 2: standard pressure 14 to 16 mm Hg (n = 31). | |
Outcomes | The outcome reported was hospital stay. | |
Notes | Reason for postrandomisation dropouts was not stated. We were unable to contact the trial authors in December 2008. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: This information was not available. |
Allocation concealment (selection bias) | Unclear risk | Comment: This information was not available. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Quote: "Die Vorlage der Analog skalzt erfolgte im Blindversuch, das heißt durch eine Person, der nicht bekannt war, welcher der beiden Versuchsgrttppen der Patient zugeordnet worden war" (Translation: pain scores were recorded by a person who was not aware of patient groups). |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: Postrandomisation dropouts were reported. |
Selective reporting (reporting bias) | High risk | Comment: Important outcomes such as mortality and morbidity were not reported. |
For‐profit bias? | Unclear risk | Comment: This information was not available. |