Transoral incisionless fundoplication (TIF) has become a widely used intervention to restore the valve at the gastroesophageal junction in selected patients suffering from gastroesophageal reflux disease (GERD). More than 20,000 procedures have been performed worldwide. TIF with EsophyX device reconfigures the tissue to establish an omega-shaped full-thickness gastroesophageal valve from inside the stomach. The procedure creates serosa to serosa plications which include the muscle layers and constructs valves 3-5cm long, taking in 200-270 degrees of the circumference, and deploying multiple non-absorbable polypropylene fasteners through the two layers in a circumferential patten around the gastroesophageal junction. Data so far indicate that, in the majority of patients, the procedure achieves lasting improvement in GERD symptoms measured by either pH or impedance monitoring. The technique offers an acceptable alternative to surgery, mimicking partial fundoplication, but less invasive and with no persistent side effects, in patients with proven pathological GERD with either a competent gastroesophageal valve or hiatal hernia, not longer than 3cm, who refuse, are intolerance, or are unresponsive to PPI maintenance therapy. Laparoscopic fundoplication, although still considered to be the gold-standard approach for GERD refractory to medical treatment, does involve some risk of long-term adverse events such as dysphagia (5-12%), inability to vomit or belch, gas/bloat syndrome (19%) and excessive flatulence.
Several prospective observational studies and some comparative trials have proved efficacy of TIF with EsophyX in obtaining a significant reduction in the acid exposure time (AET) assessed by esophageal 24-hour pH-impedance monitoring versus sham, and in controlling both typical and atypical GERD symptoms for up to 1 to 2 years, as reported in a meta-analysis7. Outcomes at 3, 5, and 10 years have been reported in different studies and showed to be favourable. In an Italian study reporting the 10 year follow-up, the GERD-HRQL score, heartburn and regurgitation score were significantly lower than pre-procedure and did not change significantly during the follow-up. The rates of patients who had stopped or halved anti-secretive therapy 2, 3, 5, 7 and 10 years after the procedure were 86.7%, 84.4%, 73.5%, 83.3% and 91.7% respectively.
This procedure, however, has not been performed in Asia patients. Asians have smaller body build and is known to have less GERD when compared to the Caucasian population. This study, therefore, is a feasibility study to perform TIF in an Asian population.
In patients who fulfil the inclusion criteria, TIF will be performe under general anaesthesia. They will then be followed-up at 4 weeks, 3 months, then yearly for up to 5 years after the procedure. The anti-reflux control and adverse events will be recorded.
18 years - 80 years of age
More than 6 months of GERD symptoms and troublesome regurgitation, despite a minimum PPI dose of 40 mg daily. Troublesome regurgitation was defined as mild symptoms for 2 or more days per week or moderate to severe symptoms more than 1 day per week, per Montreal consensus criteria. Patients will be followed-up for 5 years.
Symptom assessment used the following 3 validated tools: the Reflux Disease Questionnaire (RDQ), and the GERD-QOL score on PPI and off PPI for at least 7 days.
Abnormal amounts of gastroesophageal reflux off PPI for 7 days was confirmed by distal esophageal pH <4 for >5.3% of at least 1 of the 2 days that pH was measured with a Bravo (radiotelemetry) probe (Given Imaging, Yoqneam, Israel).
Systemic disease not well controlled
Obesity determined by body mass index >35
Esophageal ulcer, stricture
Barrett's esophagus >2 cm in length
Single group
Transoral incisional fundoplication
Procedure/SurgeryTransoral incisional fundoplication offered for GERD patients. This procedure, however, has not been performed in Asia patients, even with previous success with other studies. Asians have smaller body build and is known to have less GERD when compared to the Caucasian population. This study, therefore, is a feasibility study to perform TIF in an Asian population
Elimination of Regurgitation and Troublesome Atypical Symptoms - RDQ
Elimination of troublesome regurgitation and elimination of all troublesome atypical symptoms at the 1-year follow-up as evaluated by the Reflux Disease Questionnaire (RDQ). RDQ with total score ranging from 0 to 18 based on symptom frequency over the past week. Higher score indicates a higher likelihood of GERD, and it is also used to measure treatment response.
Elimination of Regurgitation and Troublesome Atypical Symptoms - GERD-QOL
Elimination of troublesome regurgitation and elimination of all troublesome atypical symptoms at the 1-year follow-up as evaluated by the GERD-QOL score.
Improvement of Symptom Scores - RDQ
Measuring the improvement in symptom scores using the (RDQ) at 4 Weeks, 3, 12, 24, 36, 48, 60 months post-TIF. RDQ with total score ranging from 0 to 18 based on symptom frequency over the past week. Higher score indicates a higher likelihood of GERD, and it is also used to measure treatment response.
Improvement of Symptom Scores - GERD-QOL on PPI
Measuring the improvement in symptom scores using the GERD-QOL score on PPI at 4 Weeks, 3, 12, 24, 36, 48, 60 months post-TIF. The GERD-QOL questionnaire is an 18-item instrument assessing the impact of gastroesophageal reflux disease on daily life, including sleep, diet, work, and social activity over the past 7 days. It uses a 5-point scale per item (0=Strongly agree to 4=Strongly disagree), where a higher score indicates a better quality of life.
Improvement of Symptom Scores - GERD-QOL off PPI
Measuring the improvement in symptom scores using the GERD-QOL score off PP at 4 Weeks, 3, 12, 24, 36, 48, 60 months post-TIF
Dosage and Frequency of Proton Pump Inhibitors Usage
The usage of proton pump inhibitor, that is dosage of frequency of its use for the patients will be recorded
Click on the lead sponsor to view all of their trials.
