The Reflux and BariClip: Initial Results and Mechanism of Action.

Abstract

Laparoscopic BariClip Gastroplasty (LBCG) represents a new bariatric procedure that mimics the principle of the Laparoscopic Sleeve Gastrectomy (LSG), but using a completely reversible mechanism, which is essential for gastroesophageal reflux disease (GERD). The purpose of our study was to evaluate the evolution of GERD following the initial experience with LBCG. The first 43 obese patients who underwent LBCG performed by the same surgeon in two different medical centers in May 2018-December 2019 were included in the current study. Twelve patients had issues of reflux, regularly receiving PPIs (proton pump inhibitors) treatment in eight cases, and occasionally in four cases. Thirty-two patients completed the follow-up at one year and the GERD was evaluated using the PPI medications and the GerdQ. The median preoperative GerdQ score was (14.58 ± 1.9). Three patients out of the twelve who had complained about preoperative GERD did not consent to the one year follow-up form. For the rest of nine patients, the median post-operative GerdQ score was (10.11 ± 3.2). The PPIs were used at one year follow-up in six patients: four with occasional use, one patient with regular use showing no improvement, and one who experienced de novo GERD symptomatology (3.1%). No statistically significant difference between the groups was recorded in terms of GERD. We recorded no intraoperative complications. No case of erosion occurred in the post-operative period, but we encountered two cases of slippage. One additional BariClip was removed at 14 months. LBCG represents a new bariatric procedure that mimics the principle of the laparoscopic sleeve gastrectomy, but with a completely reversible mechanism. Even with limited cases, our experience reports several mechanisms of action that will be evaluated and discussed in further prospective clinical trials. After this preliminary clinical study, LBCG's effects on GERD and its safety are highly encouraging.