Isaksson 1996.
Methods | Randomised trial.
A. Generation of allocation sequence: unclear. Randomisation mentioned but method not specified.
B. Allocation concealment: adequate. Sealed opaque envelopes.
C. Blinding: unclear. No information.
D. Follow‐up: inadequate.
Inclusion of all randomised participants at evaluation: incomplete information. Time from bleeding episode to randomisation and treatment: not specified, but patients were included after their variceal bleeding was arrested with emergency endoscopic sclerosis and if they fulfilled the entry criteria. Total number of patients evaluated: 228. Randomised to shunt: 24, randomised to ET: 21. Adequate reasons provided for those not randomised: yes. No patient was crossed over. No losses to follow‐up. Intention to treat analysis. Follow‐up period in months (mean): shunt 69.5, ET 60.2. Assessment of suitability for shunt carried out prior to randomisation: not specified. Method of Child's grading: Child's (version not specified). Method of encephalopathy testing: clinical and psychometric testing. Rebleeding episodes endoscopically verified: not specified. Specified whether rebleeding episode clinically significant: yes. (Isaksson et al. were unable to assess encephalopathy in 7/24 patients in the shunt group and in 5/21 group in the ET group). |
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Participants | Inclusion criteria: age between 20 to 75 years, endoscopically verified varices as the source of bleeding, portal hypertension, biopsy confirmed cirrhosis. Exclusions: not specified. Patients comparable in‐terms of age and Child's status but alcoholics slightly greater in the ES group. |
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Interventions | ET:
Sclerotherapy, submucosal, and paravariceal technique, sclerosant = ethoxy‐sclerol. Shunt: Interpositional 14 mm mesocaval Goretex shunt. |
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Outcomes | Survival. Rebleeding. Encephalopathy. Complications. Cost and hospital stay. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |