PURPOSE: The present randomised pilot trial was designed to compare robot-assisted (RALF) and conventional laparoscopic fundoplication (CLF) focussing on post-operative quality of life (QOL) and functional outcome. Any long-lasting advantages for patients in this regard could be a justification for the use of RALF for the treatment of gastroesophageal reflux disease (GERD). METHODS:Forty patients with GERD were randomised to either RALF or to CLF. During a follow-up period of 12 months, patients' QOL and functional outcome were investigated using disease-specific questionnaires. RESULTS: There were no significant differences in the mean QOL (1.3 versus 1.1; P = 0.374) and functional outcome (1.27 versus 1.3; P = 0.913) between both groups. Minor side effects such as bloating and persistent diarrhoea were present in four patients of each group. CONCLUSION: The present study did not show any benefit for RALF over CLF regarding QOL and functional outcome at 12 months' follow-up.
RCT Entities:
PURPOSE: The present randomised pilot trial was designed to compare robot-assisted (RALF) and conventional laparoscopic fundoplication (CLF) focussing on post-operative quality of life (QOL) and functional outcome. Any long-lasting advantages for patients in this regard could be a justification for the use of RALF for the treatment of gastroesophageal reflux disease (GERD). METHODS: Forty patients with GERD were randomised to either RALF or to CLF. During a follow-up period of 12 months, patients' QOL and functional outcome were investigated using disease-specific questionnaires. RESULTS: There were no significant differences in the mean QOL (1.3 versus 1.1; P = 0.374) and functional outcome (1.27 versus 1.3; P = 0.913) between both groups. Minor side effects such as bloating and persistent diarrhoea were present in four patients of each group. CONCLUSION: The present study did not show any benefit for RALF over CLF regarding QOL and functional outcome at 12 months' follow-up.
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