Esophageal Diseases
Conditions
Brief 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.
Detailed description
. Primary objective - • To study the incidence of true reflux on 24 hour pH analysis with manual study. Secondary objective - * To analyse treatment success which is defined as Eckdart score \< 3 at follow up assessment ( 3rd month) * To analyse the recovery of peristalsis after POEM using High resolution manometry * To study total procedure time , intra operative adverse effects and duration of hospital stay. * Severity of oesophagitis * Presence of GERD symptoms based on GERD questionnaire & Quality of life questionaire post procedure.
Interventions
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.
Sponsors
Asian Institute of Gastroenterology, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adult \>18 years * Diagnosis of Type 2 Achalasia cardia based on High resolution manometry.
Exclusion criteria
* Patients with Type 1 & 3 ACHALASIA CARDIA * Patients with previous endoscopic or surgical treatment for achalasia * Patients with standard
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of true reflux based on 24-hour pH impedence | 3 months | Reflux parameters in percent are noted in impedence report like acidic and non acidic refluxes |
| Integrated Relaxation Pressure (IRP) at High resolution manometry test | 3 months | IRP in mm Hg measures pressure in the esophagus |
Countries
India
Contacts
Primary ContactRajesh Dr Goud, M.Pharm, MBA
Backup ContactSreejith Dr OT, MBBS MD
Outcome results
None listed