Planas 1991.
Methods | Randomised trial.
A. Generation of allocation sequence: unclear. Randomisation mentioned but method not specified.
B. Allocation concealment: unclear. No information.
C. Blinding: unclear. No information.
D. Follow‐up: adequate.
Inclusion of all randomised participants at evaluation: yes. Time from bleeding episode to randomisation: Three days after stabilisation following a variceal bleed. Time from randomisation to treatment, days (mean,SD): Shunt (14.7,6.3), ET (7.2,3.4). Total number of patients evaluated: 189. Randomised to SHUNT: 41, randomised to endoscopic therapy (ET): 41. Adequate reasons provided for those not randomised: yes. Seven patients in the shunt group and six in the ET group did not receive the allocated treatment. One patient in each group was lost to follow‐up. Intention to treat analysis. Mean follow‐up period in months (SD): SHUNT 20.9 (13.9), ET 20.8 (15). Assessment of suitability for shunt carried out prior to randomisation: no. Method of Child's grading: Child‐Campbell. Method of Encephalopathy testing: clinical testing and history. Rebleeding episodes endoscopically verified: yes. Specified whether rebleeding episode clinically significant: not specified. |
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Participants | Inclusion criteria: Child‐Campbell A and B cirrhotic patients who were considered following endoscopically proven variceal haemorrhage. Exclusions (one or more of the following): Child‐Campbell class C, uncontrollable haemorrhage, or early rebleeding between admission and randomisation. Patient characteristics comparable, age slightly less in the ES group. |
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Interventions | ET:
Sclerotherapy, intra‐ and para‐variceal technique, sclerosant polidocanol. Shunt: End‐to‐side portocaval shunt. |
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Outcomes | Rebleeding. Encephalopathy. Mortality. Complications. Days of hospitalisation and cost. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |