Botulinum toxin injection in the upper esophageal sphincter for retrograde-cricopharyngeus dysfunction: a double blind, placebo-controlled trial.

retrograde cricopharyngeus dysfunction

Response to Botox versus placebo, 12 weeks after treatment. We will use the questionnaire of ‘Difficulties with belching’, and response is defined as at least a 50% improvement on question 6A ‘To what extent have the symptoms of 'difficulty burping air' been reduced after treatment?'.

Response to Botox versus placebo, 48 weeks after treatment. We will use the questionnaire of ‘Difficulties with belching’, and response is defined as at least a 50% improvement on question 6A ‘To what extent have the symptoms of 'difficulty burping air' been reduced after treatment?'., Safety: assessed by the number and type of (serious) adverse events that occurred in each group by week 48, and by the SSQ 1 week and 4 weeks after the procedure., Exploratory: HRQOL using EQ-5D VAS score short-term (1, 4, 12 weeks) and long-term (30 - 48 weeks after the procedure)., Exploratory: Patients experience and satisfaction of the treatment based on OTE and OSS short-term (1, 4, 12 weeks after the procedure), and long-term (20 - 48 weeks after the procedure), Exploratory: Evolution of associated gastro-intestinal symptoms short-term (1, 4, 12 weeks) and long-term (20 - 48 weeks after the procedure)., Exploratory: Change in objective measurements after, versus before BT injeciton using high resolution impedance manometry at week 20, and comparing with baseline., Exploratory: Improvement in symptoms after Botox versus placebo, 12 and 48 weeks after treatment. We will use the questionnaire of ‘Difficulties with belching’, using a cut-off for improvement of 30% on question 6A ‘To what extent have the symptoms of 'difficulty burping air' been reduced after treatment?'., Exploratory: Safety at week 12, 20 and 48 using SSQ

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