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Lower Esophageal Sphincter (LES) Stimulation in Patients With Ineffective Esophageal Motility — DYSMOSTIM  

Quality of Life Clinical Trial

Official title:
Evaluation of Gastroesophageal Reflux Disease - Health Related Quality of Life After Lower Esophageal Sphincter (LES) Stimulation in Patients With Ineffective Esophageal Motilitygus (IEM)

Clinical Trial Summary

The aim of this study is to evaluate gastroesophageal reflux disease - health related quality of life (GERD-HRQL) after electrical stimulation of the lower esophageal sphincter (LES) in patients with gastroesophageal reflux disease (GERD) and esophageal dysmotility.

Clinical Trial Description

Background The growing burden of gastroesophageal reflux disease (GERD) still impacts healthcare costs intensively. Although the treatment with proton pump inhibitor (PPI) is effective in many cases, surgical treatment remains relevant due to a large amount of PPI refractory GERD. Laparoscopic fundoplication (LF) is considered as standard procedure, but this type of surgery is linked to side effects as dysphagia, gas bloating and inability to belch. Especially patients with ineffective esophageal motility (IEM) are prone to postoperative dysphagia after LF. Lower esophageal sphincter electrical stimulation (LES-EST) was introduced as an alternative technique to avoid side effects of LF. Rodriquez et al. have bee demonstrated that LES-EST significantly raises the LES pressure and improved GERD symptoms such as heartburn and regurgitation. The advantage of this procedure is that the anatomy of the esophageal-gastric junction is not altered dramatically. Notably, patients with severely disordered esophageal peristalsis will benefit from this low-risk profile.

After successful implementation of this technique at the Medical University of Vienna (EK 1149/2014), a prospective evaluation of data with the well established gastroesophageal reflux disease - health-related quality of life is next. Patients with esophageal motility disorder, who undergo LES-EST, will be investigated towards side effects such as gas-bloating, inability to belch, flatulence and dysphagia. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03476265
Study type Interventional
Source Austrian Society Of Surgical Oncology
Contact
Status Completed
Phase N/A
Start date May 1, 2017
Completion date June 15, 2018
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