Preliminary Results of a Study Comparing Pre-sleeve Endoscopic Fundoplication to Gastric Bypass on Gastroesophageal Reflux Disease Outcomes.

BACKGROUND: Gastroesophageal reflux disease (GERD) is a significant complication of sleeve gastrectomy (SG). Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) is considered the primary treatment for bariatric surgery candidates with GERD. Post-operative options for GERD management are limited. This study compares the effect of transoral fundoplication (TF) prior to SG vs LRYGB in patients with GERD . METHODS: Of 30 consecutive bariatric surgery patients with GERD between 3/22/2018 and 6/23/2020, 15 patients underwent TF prior to SG (TF/SG) and 15 patients underwent LRYGB. Subjective and objective criteria, including the GERD Health-Related Quality of Life (HRQL) and Reflux Symptom Index (RSI) survey, were used to assess symptoms. Surveys were collected pre-operatively, post-TF/pre-SG, 4-6 and 12-15 months post bariatric procedure. RESULTS: Preoperative mean scores were as follows: HRQL 32.53, RSI 21.7, 93% proton pump inhibitor (PPI) usage, 6.5% satisfaction rate. Mean BMI: 45.99 (TF/SG), 42.27 (LRYGB). At 12-15 months postoperatively: mean HRQL scores were 5.53 (TF/SG) and 6.67 (LRYGB). Both groups had a statistically significant improvement in HRQL-RSI postoperatively. PPI usage was 13% (TF/SG) and 34% (LRYGB). BMI decrease was 24% (TF/SG) and 31% (LRYGB). CONCLUSIONS: TF/SG is at least equivalent to LRYGB in resolution or reduction of reflux symptoms at 12-15 months.

The effects of preoperative rofecoxib, metoclopramide, dexamethasone, and ondansetron on postoperative pain and nausea in patients undergoing elective laparoscopic cholecystectomy.

BACKGROUND: No trial to date has evaluated the combined effect of preoperative Rofecoxib, Metoclopramide, Dexamethasone, and Ondansetron on postoperative pain and nausea in patients undergoing laparoscopic cholecystectomy (LC). METHODS: A prospective randomized double-blinded placebo-controlled trial was conducted on patients undergoing elective LC. The patients in the intervention group received Rofecoxib 25 mg PO. Additionally the study group received Metoclopramide 10 mg and Dexamethasone 4 mg; and Ondansetron 4 mg intravenously. Pain and nausea were rated preoperatively, on arrival at the postanesthesia care unit (PACU), at points until discharge, and at 24 hours. RESULTS: 97 patients were in the control group, and 108 received intervention. The intervention group had a smaller proportion of men (10% vs. 23%; p < 0.015). There were differences in: length of stay (LOS) until discharge criteria met (12.88 vs. 9.85 hours, p = 0.0006), pain rating on arrival to floor (3.55 vs. 2.48, p = 0.003); highest pain rating (4.38 vs. 3.56, p = 0.032), highest nausea rating (2.99 vs. 1.47, p = 0.001), worst nausea since discharge (2.58 vs. 1.26, p = 0.005), and the use of postoperative anti-emetics in women (64% vs. 37.1%, p = 0.001). CONCLUSIONS: The use of this preoperative regimen resulted in decreased LOS, maximum pain, and nausea ratings. Patients in the intervention group required less postoperative anti-emetics.

Randomized sham-controlled trial evaluating efficacy and safety of endoscopic gastric plication for primary obesity: The ESSENTIAL trial.

OBJECTIVE: Evaluate safety and efficacy of the pose™ procedure for obesity treatment. METHODS: Subjects with Class I to II obesity were randomized (2:1) to receive active or sham procedure, after each investigator performed unblinded lead-in cases. All subjects were provided low-intensity lifestyle therapy. Efficacy end points were the mean difference in percent total body weight loss (%TBWL) at 12 months between randomized groups, and responder rate achieving ≥5% TBWL. The primary safety end point was incidence of reported adverse events. RESULTS: Three hundred thirty-two subjects were randomized (active, n = 221; sham, n = 111); thirty-four subjects were included in the unblinded lead-in cohort. Twelve-month results were mean TBWL 7.0 ± 7.4% in lead-in, 4.95 ± 7.04% in active, and 1.38 ± 5.58% in sham groups, respectively. Responder rate was 41.55% in active and 22.11% in sham groups, respectively (P < 0.0001); mean responder result was 11.5% TBWL. The differences observed between active and sham groups for co-primary end points were statistically significant (P < 0.0001); however, super superiority margin as set forth in the study design was not met. No unanticipated adverse events or deaths occurred. Procedure-related serious adverse event rates were 5.0% (active) and 0.9% (sham), P = 0.068. CONCLUSIONS: The pose procedure was safe and resulted in statistically significant and clinically meaningful weight loss over sham through 1 year.