The RAP clinical trial: Safety of a novel endoscopic technique for post laparoscopic sleeve gastrectomy patients with severe reflux

Not Applicable

Recruiting

• Conditions: Gastrointestinal reflux; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12620000646943
• Lead Sponsor: Royal Brisbane Women's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-04
• Last Update Posted: 31 January 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement of adverse events to develop a safety profile, over 12 months<br>*Have you needed to see your local doctor or visited the hospital since you had the procedure / or since we last contacted you? Yes / No<br>If yes, details will be collected and adverse events will be categorised for reporting[Weekly for 6 weeks<br>At 3 months, 6 months, 9 months and 12 months]