Assessing the safety of a novel endoscopic resection and plication (RAP) technique in post laparoscopic sleeve gastrectomy patients with severe reflux: a pilot clinical trial

Royal Brisbane Women's Hospital0 个研究点目标入组 10 人开始时间: 2020年6月4日最近更新: 2022年1月31日

适应症

试验速览

暂无简介。

•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.

•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)

发起方

Royal Brisbane Women's Hospital