No relevant difference in quality of life and functional outcome at 12 months' follow-up-a randomised controlled trial comparing robot-assisted versus conventional laparoscopic Nissen fundoplication.
OBJECTIVE
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.


CONCLUSIONS
The present study did not show any benefit for RALF over CLF regarding QOL and functional outcome at 12 months' follow-up.
Müller-Stich
B P
BP
Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.
Reiter
M A
MA
Mehrabi
A
A
Wente
M N
MN
Fischer
L
L
Köninger
J
J
Gutt
C N
CN
D016009:Chi-Square Distribution; D005260:Female; D018662:Fundoplication / Q000379:methods*; D005764:Gastroesophageal Reflux / Q000601:surgery*; D006801:Humans; D010535:Laparoscopy; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011788:Quality of Life; D020127:Recovery of Function; D012371:Robotics; D018709:Statistics, Nonparametric; D011795:Surveys and Questionnaires; D016896:Treatment Outcome