STRETTA-BMI
Research type
Research Study
Full title
Patient Reported Outcome Measures (PROM) Analysis of Endoscopic Non-Ablative Radio Frequency Energy Delivery to the Lower Oesophageal Sphincter (STRETTA® procedure) in patients with Gastro-Oesophageal Reflux Disease as stratified by their body mass index (BMI)
IRAS ID
194619
Contact name
Anjan Dhar
Contact email
Sponsor organisation
County Durham and Darlington NHS Foundation Trust
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Gastro-oesophageal reflux disease (GORD) is a common disorder of the upper gastro-intestinal tract, which has a prevalence of 10-20% in the western world.
Current management of GORD include lifestyle modifications and drug therapy. Some patients with inadequate response to the above treatments may need surgical treatment with an open or laparoscopic (key-hole) anti-reflux surgery.
Stretta® is a minimally invasive endoscopic treatment that uses a balloon based catheter passed through an endoscope to provide non-ablative radiofrequency (NARF) energy treatment to the muscle between the gullet and stomach (lower oesophageal sphincter muscle). Radiofrequency energy has already been widely used in many medical specialties. This localised treatment to the muscle at the lower end of the gullet is aimed to strengthen the valve function of the sphincter, and reduce the reflux of acid from the stomach to the oesophagus, thereby improving symptoms of GORD. The efficacy and safety of the procedure has been established over the last few years and Stretta® has emerged as an alternative to anti-reflux surgery in selected patients. The efficacy of the Stretta® procedure in obese patients as compared to non-obese patients is yet to be established.
The research question that we wish to answer from this study is whether non-surgical endoscopic treatment by Stretta® is effective treatment for management of GORD in obese patients as compared to non-obese patients, especially those who are not deemed to be suitable for bariatric surgery (obesity surgery). This prospective consecutive study aims to address the efficacy of this procedure in patients with gastro-oesophageal reflux disease stratified by their body mass index (BMI) using standard questionnaires (symptom assessment using the GSAS and quality of life using GERD-HRQL questionnaires) and oesophageal physiology studies. Secondary outcomes measured will include GORD medication dependence post Stretta® procedure.REC name
South East Scotland REC 02
REC reference
16/SS/0144
Date of REC Opinion
26 Aug 2016
REC opinion
Favourable Opinion