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. 2006 Oct 18;2006(4):CD000553. doi: 10.1002/14651858.CD000553.pub2

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).
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.
Interventions ET: 
 Sclerotherapy, submucosal, and paravariceal technique, sclerosant = ethoxy‐sclerol.
Shunt: 
 Interpositional 14 mm mesocaval Goretex shunt.
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