Poliprotect vs Omeprazole in the Relief of Heartburn, Epigastric Pain, and Burning in Patients Without Erosive Esophagitis and Gastroduodenal Lesions: A Randomized, Controlled Trial.

INTRODUCTION: In the treatment of upper GI endoscopy-negative patients with heartburn and epigastric pain or burning, antacids, antireflux agents, and mucosal protective agents are widely used, alone or as add-on treatment, to increase response to proton-pump inhibitors, which are not indicated in infancy and pregnancy and account for significant cost expenditure. METHODS: In this randomized, controlled, double-blind, double-dummy, multicenter trial assessing the efficacy and safety of mucosal protective agent Poliprotect (neoBianacid, Sansepolcro, Italy) vs omeprazole in the relief of heartburn and epigastric pain/burning, 275 endoscopy-negative outpatients were given a 4-week treatment with omeprazole (20 mg q.d.) or Poliprotect (5 times a day for the initial 2 weeks and on demand thereafter), followed by an open-label 4-week treatment period with Poliprotect on-demand. Gut microbiota change was assessed. RESULTS: A 2-week treatment with Poliprotect proved noninferior to omeprazole for symptom relief (between-group difference in the change in visual analog scale symptom score: [mean, 95% confidence interval] -5.4, -9.9 to -0.1; -6.2, -10.8 to -1.6; intention-to-treat and per-protocol populations, respectively). Poliprotect's benefit remained unaltered after shifting to on-demand intake, with no gut microbiota variation. The initial benefit of omeprazole was maintained against significantly higher use of rescue medicine sachets (mean, 95% confidence interval: Poliprotect 3.9, 2.8-5.0; omeprazole 8.2, 4.8-11.6) and associated with an increased abundance of oral cavity genera in the intestinal microbiota. No relevant adverse events were reported in either treatment arm. DISCUSSION: Poliprotect proved noninferior to standard-dose omeprazole in symptomatic patients with heartburn/epigastric burning without erosive esophagitis and gastroduodenal lesions. Gut microbiota was not affected by Poliprotect treatment. The study is registered in Clinicaltrial.gov (NCT03238534) and the EudraCT database (2015-005216-15).

Robotic Heller-Dor procedure for oesophageal achalasia: Fluorescence-guided intraoperative assessment of myotomy. A retrospective single-centre experience.

BACKGROUND: The robotic Heller-Dor (RHD) procedure for oesophageal achalasia (EA) is safe and effective. We aim to evaluate the intraoperative use of fluorescence imaging, as an alternative means to intraoperative endoscopy, to assess myotomy at the end of the procedure. METHODS: Thirty-four patients affected with EA underwent RHD. The myotomy was assessed intraoperatively by endoscopy in group A (17 patients), and by fluorescence imaging in group B (17 patients). Perioperative and long-term results were compared. RESULTS: In group A, one mucosal tear was identified during intraoperative endoscopy. In group B, indocyanine green (ICG) helped identify residual muscle fibres in three cases. No perforation of the oesophageal mucosa occurred in group B. CONCLUSIONS: Fluorescence-imaging improved the identification of residual muscle fibres and made it possible to verify the integrity of the mucosa without the use of intraoperative endoscopy. A significant reduction in operative times has been related to the use of this technique.

Pelvic floor biofeedback is an effective treatment for severe bloating in disorders of gut-brain interaction with outlet dysfunction.

BACKGROUND: The pathophysiology of bloating is partially understood. We investigated in patients with disorders of gut-brain interaction (DGBI) the relationship between severity of bloating, abdominal girth changes and defecation pattern, and the efficacy of pelvic floor biofeedback treatment on bloating. METHODS: Disorders of gut-brain interaction patients with severe bloating as the main complaint were prescribed 2 weeks dietary advice and underwent abdominal girth measurements. At the first visit, all patients underwent a questionnaire on the subjective improvement of bloating, a (0-100) VAS abdominal bloating, and abdominal girth measurement. Patients reporting inadequate bloating relief underwent a standardized balloon expulsion test. Furthermore, they were invited to undergo pelvic floor electromyography and biofeedback treatment previously used for constipation due to dyssynergic defecation. The primary outcome was bloating improvement on a 5-point Likert scale. The secondary outcomes were the effect of diet intervention and pelvic floor biofeedback treatment on bloating severity and quality of life changes as well as the effect of pelvic floor biofeedback treatment on BET and EMG on straining. KEY RESULTS: One hundred and fifty six patients (129 F, 39.3 ± 11.7 mean age) completed the 2-week run-in period. 105 patients were diet non-responder and underwent balloon expulsion test, with the vast majority (64%) failing the test. Patients who scored higher bloating on VAS had a significant association with failed balloon expulsion test (adjusted B 0.4 [95% CI 10.8-25.7], p < 0.0001). 63% agreed to perform pelvic floor biofeedback treatment at Verona center, 54% became responders reporting fair or major improvement/cure (ITT analysis, McNemar test, p < 0.0001), and all of them showed a 50% decrease in bloating severity. CONCLUSIONS AND INFERENCES: Disordered defecation is a prevalent etiology in DGBI patients with bloating unresponsive to conservative measures; pelvic floor biofeedback treatment to improve the defecation effort significantly relieved bloating (http://www.isrctn.com, ISRCTN17004079).

Efficacy of Prucalopride in bowel cleansing before colonoscopy: Results of a pilot study.

Colonoscopy is a crucial diagnostic instrument for colorectal cancer screening and an adequate bowel preparation is definitely decisive for the success of the procedure. Especially in elderly patients, bowel cleansing is considered a big issue, because it is often poorly tolerated for many reasons (like inability to swallow large volume of liquids or unlikable taste); this can cause a suboptimal preparation that may lead to miss a neoplastic lesion. There is relatively little data about how to improve preparation tolerability. The purpose of our pilot study was to analyze the effect of prucalopride (Resolor®), a highly selective serotonin 5HT4 receptor agonist used for chronic constipation for its ability to stimulate gastrointestinal peristalsis, undertaken the day before colonoscopy, followed by half volume of polyethylene glycol solution. We found that this can be a good and safe method to achieve an adequate and better-tolerated colon cleansing.

Preoperative colonoscopy after self-expandable metallic stent placement in patients with acute neoplastic colon obstruction.

BACKGROUND: In patients with colorectal cancer, a preoperative colonoscopy is recommended to exclude synchronous lesions. Unfortunately, between 7% and 29% of patients with colorectal cancer present with acute colonic obstruction, making complete colonoscopy impossible. OBJECTIVE: The aim of our study was to evaluate the feasibility of a preoperative colonoscopy after effective stent placement in patients with acute neoplastic obstruction. DESIGN: Single-center prospective study. SETTING: All examinations were carried out at a tertiary referral center with 24-hour emergency endoscopy service. PATIENTS: Fifty-seven patients with acute neoplastic colon obstruction. INTERVENTIONS: Patients who recovered from an acute colon obstruction by an effective stent placement and who had a resectable cancer underwent a preoperative colonoscopy. MAIN OUTCOME MEASUREMENTS: Patients with a resectable cancer, complete preoperative colonoscopies, and synchronous lesions rates. RESULTS: Self-expandable metallic stents (SEMS) were placed in 50 of 57 patients (87.8%). Thirty-one of 50 patients had a resectable cancer (62%), and a complete preoperative colonoscopy was possible in 29 of 31 patients (93.4%). A synchronous cancer was detected in 3 patients (9.6%), changing the surgical plan. LIMITATIONS: Seven patients in whom the SEMS placement (12.2%) was unsuccessful underwent an urgent surgical intervention. Nineteen of 50 patients who had stent placement were not eligible for our study because of unresectable cancer. CONCLUSIONS: Our study indicates that it is feasible in a majority of patients to perform full preoperative colonoscopy after relief of acute colonic obstruction with SEMS before surgical resection.

Routine ileoscopy at colonoscopy: a prospective evaluation of learning curve and skill-keeping line.

BACKGROUND: Ileoscopy is the criterion standard for mucosal lesions of terminal ileum but is performed in 5% of colonoscopy activity, and the need for training is undefined. OBJECTIVE: To assess the learning curve and skill-keeping line of ileoscopy. DESIGN: Prospective randomized study. SETTING: Single GI endoscopy unit. PATIENTS: Adult outpatients referred for colonoscopy. INTERVENTIONS: Patient randomization to ileocolonoscopy by trainees and seniors. MAIN OUTCOME MEASUREMENTS: Ileoscopy skill was divided into the following: ileocecal valve (ICV) intubation (success rate, time) and ileal exploration (length, time). Consecutive blocks of 10 procedures were used to calculate the learning curve and the skill-keeping line. Variables considered to influence ICV intubation were the following: endoscopist experience, ICV morphology, patient age, gender, body mass index, diverticular disease, and preceding abdominal/pelvic surgery. RESULTS: Learning curve showed that competency in ICV intubation (80% success rate) and ileal exploration (16 cm) was achieved after 50 procedures. The skill-keeping line showed that ileoscopy was easy (97% success rate), fast (1 minute), and well accepted up to 45 cm of the ileum. Thin-lipped and volcanic ICV are the most difficult and easiest to intubate, respectively. Crohn's disease and adenomas of the proximal edge of ICV were diagnosed in 2.2%. CONCLUSIONS: Training in ileoscopy is recommended to achieve competency, and endoscopists should consider practicing ICV intubation to maintain and increase their skill. Ileoscopy can be difficult when the ICV is thin lipped or single bulged, and easy when it has a volcanic morphology.