\- 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 - * 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
158
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.
Asian Institute of Gastroenterology /Aig Hospitals
Hyderabad, Telangana, India
RECRUITINGIncidence of true reflux based on 24-hour pH impedence
Reflux parameters in percent are noted in impedence report like acidic and non acidic refluxes
Time frame: 3 months
Integrated Relaxation Pressure (IRP) at High resolution manometry test
IRP in mm Hg measures pressure in the esophagus
Time frame: 3 months
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