NCT03476265

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Austrian Society Of Surgical Oncology · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Quality of Life
• Dysphagia
• Electrical Stimulation of the Lower Esophageal Sphincter
• Gastro Esophageal Reflux

Interventions

Type	Name	Description
DEVICE	Electrical Stimulation of the Lower Esophageal Sphincter	Laparoscopic implantation of an electrical stimulation device to perform an electrical sphincter augmentation for the treatment of GERD.

Timeline

• Start date: 2017-05-01
• Primary completion: 2018-01-15
• Completion: 2018-06-15
• First posted: 2018-03-26
• Last updated: 2019-07-05

Locations

1 site across 1 country: Austria