A Real-World, Insurance-Based Algorithm Using the Two-Fold Running Suture Technique for Transoral Outlet Reduction for Weight Regain and Dumping Syndrome After Roux-En-Y Gastric Bypass.

BACKGROUND AND AIMS: Transoral outlet reduction (TORe) by devitalization and/or endoscopic suturing (ES) has been implemented in the management of weight regain post-RYGB. This study aims to assess the efficacy and safety of TORe following an insurance-based algorithm. METHODS: A prospectively maintained database of patients who underwent TORe between September 2015 and January 2018 at a single academic center was reviewed. An algorithm was followed whereby management was based on insurance coverage. As part of the algorithm, all patients presented for a repeat endoscopy at 8 weeks. Patients did not receive any diet, lifestyle intervention, or pharmacotherapy. RESULTS: In total, 55 patients were included (median age 48 years), out of which 50 were females (90.9%). Patients presented for evaluation at a mean of 8.7 years post-RYGB. The main presenting symptom was combined dumping syndrome (DS) and weight regain (49.1%), followed by weight regain alone (45.5%). Twenty-nine patients required treatment at their second procedure, and 11 required treatment at their third procedure. Average percent total body weight loss (%TBWL) after TORe observed at 3-, 6-, 9-, and 12-month follow-up was 8.2, 9.3, 8.4, and 5.5%, respectively. The mean DS Severity Score was significantly reduced from 23.3 ± 12.4 before TORe to 16.3 ± 6.51 after TORe (p < 0.01). The adverse event rate from TORe was 14.5%. CONCLUSION: TORe is effective in halting ongoing weight regain and achieving moderate short-term weight loss as well as improving DS in post-RYGB patients. Durability at 1 year remains questionable due to weight recidivism.

Using biorelevant dissolution to obtain IVIVC of solid dosage forms containing a poorly-soluble model compound.

The usefulness of selected biorelevant dissolution media (BDM) to predict in vivo drug absorption was studied. Dissolution profiles of solid formulations of a poorly soluble model compound were compared in BDM simulating fasted and two levels of fed state. A non-physiologically relevant medium containing the cationic surfactant, cetrimide, was also investigated. All the media studied were capable of differentiating between the formulations employed, with formulation A consistently ranking high and formulations C and D ranking low. An in vivo dog study was carried out and an attempt was made to obtain a level A correlation between the plasma absorption curves and in vitro dissolution curves, using non-linear regression software. The in vitro-in vivo correlation (IVIVC) models developed indicated that fed state media (BDM 3) containing high levels of both bile salts (BS) and lipolysis products (LP) were best able to predict in vivo pharmacokinetic parameters (Cmax and AUC) with prediction errors lower than 10%. Overall, design and use of appropriate media for in vitro dissolution is extremely important. This study demonstrates the potential of physiologically relevant media containing both BS and LP for use in formulation and early drug development.