Standard Versus Oesophago-gastric Junction Complex Myotomy for Treatment naïve Type 2 Achalasia Patients
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
\- Consecutive eligible patients will be randomized in a 1:1 ratio to esophagogastric complex only myotomy or standard myotomy groups. Randomization is done according to the computer-generated algorithm. A clinical research coordinator will prepare the sealed randomization envelops and will hand over to the operating endoscopists before the beginning of the procedure. Written informed consent will be obtained from all participants. In this study, the participants and the care-provider assessing the clinical response to the POEM procedure at 3months will be blinded to the allocation.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Adult \>18 years
• Diagnosis of Type 2 Achalasia cardia based on High resolution manometry.
Locations
Other Locations
India
Asian Institute of Gastroenterology /Aig Hospitals
RECRUITING
Hyderabad
Contact Information
Primary
Rajesh Dr Goud, M.Pharm, MBA
rajeshgoud761@gmail.com
04023378888
Backup
Sreejith Dr OT, MBBS MD
sreeju246@gmail.com
04023378888
Time Frame
Start Date: 2023-11-29
Estimated Completion Date: 2025-07-30
Participants
Target number of participants: 158
Treatments
Active_comparator: Per oral endoscopy myotomy for standard myotomy
Standard myotomy is muscle fibers cutting in esophagus more than 7 cms
Sham_comparator: Per oral endoscopy myotomy for esophago gastric junction myotomy
Myotomy is muscle fibers cutting in esophagus less than 3 cms.
Related Therapeutic Areas
Sponsors
Leads: Asian Institute of Gastroenterology, India