Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
- 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.
. Primary objective -
• To study the incidence of true reflux on 24 hour pH analysis with manual study.
Secondary objective -
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Per oral endoscopy myotomy for standard myotomy | Active Comparator | Standard myotomy is muscle fibers cutting in esophagus more than 7 cms |
|
| Per oral endoscopy myotomy for esophago gastric junction myotomy | Sham Comparator | Myotomy is muscle fibers cutting in esophagus less than 3 cms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Per oral endoscopy myotomy | Device | Poem procedure is meant for cutting of circular and longitudinal muscle fibers in esophagus to reduce the symptoms of dysphagia, regurgitation and chestpain, weight loss. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of true reflux based on 24-hour pH impedence | Reflux parameters in percent are noted in impedence report like acidic and non acidic refluxes | 3 months |
| Integrated Relaxation Pressure (IRP) at High resolution manometry test | IRP in mm Hg measures pressure in the esophagus | 3 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rajesh Dr Goud, M.Pharm, MBA | Contact | 04023378888 | 204 | rajeshgoud761@gmail.com |
| Sreejith Dr OT, MBBS MD | Contact | 04023378888 | 500 | sreeju246@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mohan Dr Ramchandani, MBBS MD | AIG Hospitals | Study Director |
| Zaheer Dr Nabi, MBBS MD | AIG Hospitals | Principal Investigator |
| Pradev Dr Inovolu, MBBS MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asian Institute of Gastroenterology /Aig Hospitals | Recruiting | Hyderabad | Telangana | 500082 | India |
Not provided
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| AIG Hospitals |
| Principal Investigator |