Comparative Assessment of Reflux Esophagitis in Cases With and Without Esophageal Motility Disorders

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Achalasia is a neuro-degenerative disorder marked by changes in the peristalsis of the esophagus and the lack of relaxation in the lower esophageal sphincter (LES), thought to be due to damage to the myenteric plexus with an unknown cause.1 Per-oral endoscopic myotomy (POEM) is an established endoscopic treatment modality for achalasia. Leading gastrointestinal (GI) societies endorse POEM as one of the primary treatment option for achalasia.This study aims to characterize and compare the morphological characteristics of reflux related erosions after the POEM procedures versus those in cases without esophageal motility disorders. Data collection 1. Demographic characteristics: Age, gender, type of achalasia 2. Manometry findings (pre and post POEM): integrated relaxation pressure, lower esophageal sphincter pressure 3. Comorbidities 4. Medications 5. Eckardt score: before procedure and 3-months after Procedure 6. POEM procedure details: length of esophageal and gastric myotomy, adverse events, length of hospital stay 7. Evaluation at 3-months Symptom: standardized questionnaire (GERDQ) Endoscopy: grade of esophagitis Erosions vs ulcers Dimension of erosions Anatomical location (according to clock)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age≥18y,

• confirmed diagnosis of Achalasia,

• No contraindication to POEM,

• erosive esophagitis on endoscopy

Locations
Other Locations
India
Asian Institute of Gastroenterology Hospital
RECRUITING
Hyderabad
Contact Information
Primary
Rajesh Goud Mr Maragoni, M.Pharm, MBA
rajeshgoud761@gmail.com
04023378888
Backup
Zaheer Nabi Dr Mohammed, MBBS MD
zaheernabi1978@gmail.com
04023378888
Time Frame
Start Date: 2024-05-11
Estimated Completion Date: 2025-05-10
Participants
Target number of participants: 200
Treatments
Active_comparator: Assesment of reflux esophagitis in cases with esophageal motility
Reflux esophagitis can be found in Endoscopy report.
Placebo_comparator: Assesment of reflux esophagitis in cases without esophageal motility
Reflux esophagitis can be found in cases in normal gastroesophageal reflux disease condition patients
Sponsors
Leads: Asian Institute of Gastroenterology, India

This content was sourced from clinicaltrials.gov