Endoscopic versus Surgical Treatment of Reflux

INTERVENTION: ARMA: (Anti‐reflu Xmucosal ablation). This will usually be performed under local sedation (where you will still be breathing on your own). Here the junction is lasered, which as it heals and scars, tightens the junction. This is called anti‐reflu Xmucosal ablation (AMRA). i.e. Ablation of gastro‐oesophageal junction with argon plasma coagulation to create ulceration, fibrosis and subsequent constriction and tightening of the junction to prevent reflux. Performed by Gastroenterologist. Procedure recorded on clinical record. Estimated time: 30 minutes. Equipment: APC (Argon plasma coagulation) generator & straight fire probe EMR (endoscopic mucosal resection) solution – saline with 0.5% methylene blue Clear endoscope cap Specify endoscope with adequate fle X(ie older scope) IV (intravenous) omeprazole and antiemetic as part of sedation ERBE Vio‐200D Effect 3 100W (Mexican), VIO300D Effect 2 50W (Japanese) Procedure • Evaluate & clean GOJ (Gastro‐oesophageal junction) & Hill Grade • Mark borders of ablation; Effect 2 soft coagulation o Markers around inner border 1cm from GOJ, o Markers either side of 1cm greater curve untouched segment (<90o) o Markers on outer border 1‐2cm width, horse‐shoe shape • Lift cushion with EMR solution • Sequential Ablation with ERBE • Scrape/Clear tissue with cap • Complete ablation if necessary CONDITION: Oral and Gastrointestinal ‐ Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon Reflux; ; Reflux Surgery ‐ Surgical techniques PRIMARY OUTCOME: 24hr pH exposure (as assessed at pH testing) within normal range; ; [Baseline (pre‐procedure), then 6 months post‐procedure.] The Gastroesophageal Reflux Disease‐Health Related Quality of Life (GERD‐HRQL) score [6 months post procedure] SECONDARY OUTCOME: Blood loss as noted from surgical records[Post procedure] Complications: ; Dysphagia ; Gas‐Bloating ; Diarrhoea ; ; As directly asked to patient in follow‐up clinic (noted on medical record)[Within 6 months post procedure] Complications: readmission, bleeding, or pain as noted from medical record [30 days post procedure] GERD‐HRQL quality of life outcome[Yearly for 3 years post procedure] Hospital length of stay from medical records[At time of discharge] Mortality (death)[30 days post procedure] Narcotic discontinuation / return to ADL (activities of daily living) ‐ as advised by patient documented in medical record[Post‐procedure and discharge from hospital] Need for further procedure (either dilation or fundoplication) ‐ as noted from medical record[6‐12 months post procedure] Operation time as noted from surgical records[Post‐procedure] Pain as deduced from medical records[At time of discharge] QOL (quality of life) questionnaire for patients undergoing anti‐reflu Xsurgery (QOLARS)[6 months then yearly for 3 years post procedure] SHORTFORM ‐36: Medical Outcomes Study Short‐Form 36‐Item Health Survey (SF‐36)[6 months, then yearly for 3 years post procedure] INCLUSION CRITERIA: Symptomatic gastro‐oesophageal reflux, despite 2 months twice daily of PPI (proton pump inhibitor) use, and attempts to optimise lifestyle measures contributing to reflu Xevents. Confirmation of pathological reflu Xvia 24‐hr Oesophageal pH testing; either • Acid Exposure Time >6% • DeMeester Score >14.7 • Positive SAP (symptom association probability) (95%) with SI (Symptom index) >70% Or: • Los Angeles (LA) Grade C‐D oesophagitis High resolution oesophageal manometry performed in all patients to confirm the absence of major oesophageal motility disorders. Consenting to participate in trial: willing to undergo either ARMA or surgical fundoplication