High Resolution Manometry After Partial Fundoplication for Gastro-oesophageal Reflux: Does the Ineffective Preoperative Oesophageal Motility Change Postoperatively?
This is a combined retro- and prospective, monocentric study. All patients who underwent or are planned for laparoscopic partial fundoplication (180° anterior or 270° posterior) between 2020-2023 are assessed for preoperative ineffective esophageal motility (IEM). The main hypothesis is, that preoperative oesophageal motility disorders, especially hypo-contractility or failed peristalsis, are caused by gastro-oesophageal reflux. Therefore, postoperative manometry after partial wrap fundoplication (270° posterior, 180° anterior) shows a decrease in comparison to preoperative motility disorders. The primary objective of this study is to examine the postoperative esophageal motility in patients with known preoperative motility disorders. Secondary endpoints are the presence of other oesophageal motility disorders pre- vs. postoperatively (including new onset disorders), the assessment of the Gastrointestinal Symptom Rating Scale (GSRS) pre- vs. postoperatively, and more. If IEM is present preoperatively, patients are contacted at least 1 year after surgery and will be informed about the study and asked to participate. In case of agreement, they are invited to the study site. They undergo high-resolution manometry 18-24 months postoperatively (study intervention).
NCT05132816 — Gastroesophageal Reflux
Status: Recruiting
http://inclinicaltrials.com/gastroesophageal-reflux/NCT05132816/
Bile Reflux Gastropathy: Prevalence and Risk Factors After Therapeutic Biliary Interventions: A Retrospective Cohort Study
Bile reflux gastropathy is caused by the backward flow of duodenal fluid into the stomach. A retrospective cohort study was performed to declare if the therapeutic biliary interventions cause bile reflux gastropathy, and to estimate its prevalence and risk factors, and to evaluate the gastric mucosa endoscopic and histopathologic changes.
NCT05131802 — Dyspepsia
Status: Completed
http://inclinicaltrials.com/dyspepsia/NCT05131802/
Pilot Epidemiological Study to Determine the Prevalence of Pharyngolaryngeal Reflux in Patients Treated for Obstructive Sleep Apnea Syndrome
The aim of the study is to find, using validated and efficient tools, a laryngopharyngeal reflux in patients receiving polysomnography for suspected obstructive sleep apnea syndrome. It is proposed to carry out simultaneously, at the Sleep Center of the Polyclinique of Poitiers (CSPP), a polysomnography, a 24-hour Restech pharyngeal pH-metry (day and night), a Peptest (in the evening and in the morning of the polysomnography), with the RSS-12 questionnaire and the RSA score.
NCT05110352 — Obstructive Sleep Apnea
Status: Completed
http://inclinicaltrials.com/obstructive-sleep-apnea/NCT05110352/
Observational Registry of Transoral Incisionless Fundoplication (Creation of a New Gastroesophageal Valve) in Patients With Gastroesophageal Reflux Disease
This observational registry aims to: 1) record the TIF interventions in patients with esophageal or extra-esophageal symptoms; 2) to monitor the therapy response through the clinical experience in terms of effect on the use and dosage of proton pump inhibitors (PPIs) and on the GERD-Health Related Quality of Life (HRQL) and Reflux Symptom Index (RSI) questionnaires scores; 3) to characterize the treated patients population and the predictive factors of TIF success, identifying the subpopulation who may effectively benefit from TIF.
NCT05066594 — Gastro Esophageal Reflux
Status: Recruiting
http://inclinicaltrials.com/gastro-esophageal-reflux/NCT05066594/
Study Off Efficacy and Rapidity of Action of a Product With Sodium Alginate, Calcium and Magnesium Salts, Hyaluronic Acid and Aloe Vera to Control Oesophageal-Gastric Acidity (pH), Symptoms of Gastric Reflux and Hyperacidity
A Randomised, Placebo-Controlled Clinical Trial off the Efficacy and Rapidity of Action of a Product Containing Sodium Alginate, Calcium and Magnesium Salts, Hyaluronic Acid and Aloe Vera to Control Oesophageal-Gastric pH and Reduce Symptoms of Gastric Reflux and Hyperacidity.
NCT05060744 — Gastric Reflux
Status: Recruiting
http://inclinicaltrials.com/gastric-reflux/NCT05060744/
Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy
The aim of the study is to assess impact of omentopexy on de novo gastro-oesophageal reflux disease (GERD) after sleeve gastrectomy. This will be assess 2 years postoperatively. This study is a prospective, multicentric, randomized trial. Five hundred twenty six patients should be included with 263 in each arm. First arm will include patients who have a sleeve gastrectomy. The second arm will include patients who have sleeve gastrectomy with omentopexy. Two years after surgery , it will be collected a CARLSSON score and BAROS score (quality of life). The main objective is to show that omentopexy decreases the rate of de novo GERD after sleeve gastrectomy at 2 years postoperatively without the use of Proton-Pump Inhibitors (PPIs)
NCT04994665 — Obesity
Status: Recruiting
http://inclinicaltrials.com/obesity/NCT04994665/
Individualized Diagnosis and Treatment of Extraesophageal Reflux in Patients With Chronic Cough
Chronic cough is a very unpleasant symptom, significantly reduces the patient's quality of life, and bothers the neighborhood. A very common cause or co-factor of chronic cough is extraesophageal reflux (EER). The aim of the project is the precise diagnosis of EER in patients with chronic cough (in patients with a simultaneously diagnosed allergic cause and without it).
NCT04984304 — Asthma
Status: Recruiting
http://inclinicaltrials.com/asthma/NCT04984304/
Targeting Hypervigilance and Autonomic Arousal: the Psycho-physiologic Model of GERD
GERD affects roughly 20% of the U.S. population and the direct and indirect costs of GERD are substantial, totaling close to 50 billion dollars per year. Evidence supports that a large proportion of this cost and poor clinical outcomes in GERD are related to poor healthcare decisions by both the physician and the patient. The problem of inappropriate GERD management stems from three main issues. First, the disease is heterogeneous and requires treatment informed by a precision model. Second, the current paradigm largely ignores the important brain-gut interactions that drive symptoms and healthcare utilization. Third, there is a paucity of well-performed comparative effectiveness trials focused on assessing treatments beyond acid suppression. We will use physiomarkers defined during the previous funding cycle to phenotype the patients and use cognitive behavioral interventions to modulate hypervigilance to test the Psycho-Physiologic Model of GERD. Cognitive Behavioral Therapy (CBT) is able to improve hypervigilance and symptom specific autonomic arousal and thus, we will test our theory that CBT can improve outcomes in GERD by targeting these two important psychologic stressors. We will also continue our focus on the interplay of psychology and physiology by determining whether increased mucosal permeability is associated with reflux perception and whether this is modified by hypervigilance and autonomic disruption.
NCT04960566 — Gastroesophageal Reflux
Status: Enrolling by invitation
http://inclinicaltrials.com/gastroesophageal-reflux/NCT04960566/
Effect of Routine Anterior Crural Repair in De-Novo Gastroesophageal Reflux After Laparoscopic Sleeve Gastrectomy - A Randomized Control Trial
The purpose of the study is to evaluate the superiority of anterior crural repair during sleeve gastrectomy over no repair in decreasing the incidence of gastroesophageal reflux disease.
NCT04884074 — Obesity
Status: Recruiting
http://inclinicaltrials.com/obesity/NCT04884074/
Detection of Barrett s Esophagus in Patients Without Gastroesophageal Reflux Disease (GERD) Symptoms
The purpose of this study is to develop a method to detect Barrett's esophagus (BE) in individuals with a new office-based diagnostic test.
NCT04880044 — Barrett's Esophagus
Status: Recruiting
http://inclinicaltrials.com/barrett-s-esophagus/NCT04880044/