Li 2004.
Methods | Randomised clinical trial. | |
Participants | Country: China.
Number randomised: initially 31, post randomisation drop outs 0, final number of study participants 31.
Mean age: 50.2 years.
Females: 5 (16.1%).
Cirrhotic livers: 27 (87.1%).
Steatotic livers: not stated. Inclusion criteria: 1. Elective hepatic resection. 2. Portal triad clamping. 3. Diagnosis of primary hepatocellular carcinoma. |
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Interventions | Participants were randomly assigned to two groups: Intervention group 1: administered 10000 IU of ulinastatin during the operation, and twice a day with combination of vitamin K1 and glucose for 5 consecutive days after the operation (n = 16). Intervention group 2: administered gantaile (a Chinese herbal medicine used as a 'common liver protectant') the dose for which was not given, vitamin K1, and glucose (n = 15). |
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Outcomes | The outcomes reported were mortality, liver decompensation, wound infection, intra‐abdominal infection, hospital stay, blood loss, markers of liver function, and enzyme markers of liver injury. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | Quote: "sealed envelope". |
Blinding? All outcomes | High risk | Comment: trial not double blinded. |
Incomplete outcome data addressed? outcomes 2‐4 weeks | Low risk | Comment: no post randomisation drop‐outs. |
Free of selective reporting? | Low risk | Comment: all important outcomes reported. |
Free from baseline imbalance? | Low risk | Comment: no baseline imbalance in important characteristics. |
Free from academic bias? | Low risk | Comment: no previous published studies of the same comparison by the trial authors. |