Abstract
AimsNumerous reports have addressed the feasibility and safety of robotic-assisted (RALF) and conventional laparoscopic fundoplication (CLF). Long-term follow-up after direct comparison of these two minimally invasive approaches is scarce. The aim of the present study was to assess long-term disease-specific symptoms and quality of life (QOL) in patients with gastroesophageal reflux disease (GERD) treated with RALF or CLF after 12 years in the randomized ROLAF trial.MethodsIn the ROLAF trial 40 patients with GERD were randomized to RALF (n = 20) or CLF (n = 20) between August 2004 and December 2005. At 12 years after surgery, all patients were invited to complete the standardized Gastrointestinal Symptom Rating Scale (GSRS) and the Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD). Failure of treatment was assessed according to Lundell score.ResultsThe GSRS score was similar for RALF (n = 15) and CLF (n = 15) at 12 years´ follow-up (2.1 ± 0.7 vs. 2.2 ± 1.3, p = 0.740). There was no difference in QOLRAD score (RALF 6.4 ± 1.2; CLF 6.4 ± 1.5, p = 0.656) and the QOLRAD score sub items. Long-term failure of treatment according to the definition by Lundell was not different between RALF and CLF [46% (6/13) vs. 33% (4/12), p = 0.806].ConclusionIn accordance with previous short-term outcome studies, the long-term results 12 years after surgery showed no difference between RALF and CLF regarding postoperative symptoms, QOL and failure of treatment. Relief of symptoms and patient satisfaction were high after both procedures on the long-term. Registration number: DRKS00014690 (https://www.drks.de).
Highlights
12 patients were not included because 11 patients refused to participate in the study one patient had a body mass index (BMI) of more than 40 kg/m2. 40 patients were enrolled in the study and received either RALF (n = 20) or conventional laparoscopic fundoplication (CLF) (n = 20)
Gastrointestinal Symptom Rating Scale (GSRS) and quality of life in reflux and dyspepsia (QOLRAD) scores within the first 12 months did not differ between the two procedures [10]
For the long-term follow-up, the results in the present study indicate a comparably stable efficacy of RALF and CLF and most of the patients reporting an overall quality of life (QOL) similar to that of the general population
Summary
In the randomized ROLAF trial a total of 40 patients were operated in 2004–2005 in a single center. All CLF procedures were carried out by surgeons who had previously performed more than 30 CLF procedures and had completed their learning curve [12] Both CLF and RALF were performed with a Nissen fundoplication. In the literature at the time the original ROLAF trial was conducted, a range of 20–30 procedures was considered to be the necessary number that a robotic surgeon must have completed to be considered experienced [14]. Study bias due to the fact that RALF was only performed by one surgeon as opposed to a total of three surgeons who performed CLF cannot be excluded This bias was minimized by the fact that all participating surgeons were highly experienced in the procedures performed by them as part of the study and by high standardization of the surgical technique. And mid-term results of the ROLAF trial have been published before [10, 11]
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