None listed
Conditions
Brief summary
The primary purpose of the clinical trial is so establish a safety profile for the RAP (resection and plication) technique in patients who are experiencing severe reflux symptoms post laparoscopic sleeve gastrectomy. Endoscopic anti-reflux therapy is an emerging treatment considered for selected patients with gastro-oesophageal reflux disease that have a history of ongoing symptoms despite standard treatment. Additionally, the trial will measure quality of life measures, effects on reflux symptoms,endoscopic data points, medication usage and weight changes.
Interventions
The "RAP" technique is a relatively novel endoscopic procedure conducted in bariatric patients who have undergone a laparoscopic gastric sleeve procedure and have severe reflux disease. It is conducted by senior gastroenterologists who have been credentialed in using the Overstitch device to conduct this procedure endoscopically. It is revisional surgery to anatomically improve the junction between the oesophagus and stomach to prevent stomach contents from refluxing into the oesophagus (as the
The "RAP" technique is a relatively novel endoscopic procedure conducted in bariatric patients who have undergone a laparoscopic gastric sleeve procedure and have severe reflux disease. It is conducted by senior gastroenterologists who have been credentialed in using the Overstitch device to conduct this procedure endoscopically. It is revisional surgery to anatomically improve the junction between the oesophagus and stomach to prevent stomach contents from refluxing into the oesophagus (as the anatomy has been surgically altered during the original laparoscopic sleeve gastrectomy, and patients are then prone to reflux symptoms). Some patients are managed effectively with medication but some do not respond to medication. The duration of the procedure is 45-60 minutes. Patients will stay overnight in hospital before being medically cleared for discharge the next day. The procedure involves the inside lining of the gastrointestinal tract is removed with the endoscope and then a suture is placed through the wall of the gastrointestinal tract to bunch up the muscle valve at the junction of the oesophagus and the stomach. The suture may stay in place permanently or may move over time. This then helps to prevent the contents of the stomach refluxing up into the oesophagus.
Sponsors
Royal Brisbane Women's Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
• Age between 18 and 65 years. • Typical symptoms of gastroesophageal disease that are refractory to medical therapy in patients (maximal therapy for 4 weeks) 1. That would like to avoid open/ laparoscopic surgery. 2. Who have undergone sleeve gastrectomy precluding them from open/laparoscopic anti reflux surgery • Able to understand the procedure and follow up requirements. • Voluntary agreement and signing of consent form.
Exclusion criteria
Presence of a hiatus hernia measuring equal to or greater than 3 centimetres on baseline endoscopy. • Evidence of a primary oesophageal dysmotility. • Anticoagulant or antiplatelet therapy, with the exception of Aspirin • Pregnancy or intending to become pregnant in the 12 months after ESG • Patients who lack capacity to provide written consent • Allergy to medications used for anaesthetics • Inability to return for scheduled clinic visits • Advanced medical comorbidities defined as: 1) Decompensated cirrhosis 2) Cardiac failure with NYHA class III and IV symptoms 3) COPD – Stage III and IV 4) Kidney dysfunction on dialysis 5) Active cancer undergoing treatment 6) Cerebrovascular accident causing significant functional impairment 7) Severe nutritional deficiencies 8) Recent neoplasia (less than 5 years)
Outcome results
None listed