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To Investigate the Incidence of Reflux in Patients After Per-oral Endoscopic Myotomy in Achalasia Cardia Patients

NCT04951739 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 64

Last updated 2023-01-31

No results posted yet for this study

Summary

Achalasia is a rare motility disorder of the oesophagus that is characterized by aperistalsis of the oesophagal body and dysrelaxation of the lower oesophagal sphincter (LES). Current treatment is palliative, and the aim of the treatment is to diminish the obstructive function of the esophagogastric junction (EGJ). Due to this approach, the most frequent complication post-treatment is gastroesophageal reflux (GER). However, not every treated patient develops GER symptoms and the mechanism behind the occurrence of GER in treated achalasia are unclear. In this study, we aim to Investigate the incidence of reflux in patients after peroral endoscopic myotomy in patients with achalasia cardia.

Conditions

  • Achalasia Cardia
  • Gastroesophageal Reflux

Interventions

PROCEDURE

Peroral endoscopic myotomy

Peroral endoscopic myotomy involves an initial incision on the internal lining of the oesophagus. This permits entry of the endoscope to within the wall of the oesophagus, where the muscle will be exposed. The inner layer of the muscle near the lower oesophagal sphincter will be cut (this is termed myotomy). At the conclusion of the procedure, the oesophagal incision will be closed with standard endoscopic clips.

Sponsors & Collaborators

  • Asian Institute of Gastroenterology, India

    lead OTHER

Principal Investigators

  • Aniruddha P Singh, MBBS,MD,DM · AIG hospitals,India

  • Mohan Ramchandani, MBBS,MD,DM · AIG Hospitals,India

  • Nageshwar Reddy, MBBS,MD,DM · AIG Hospitals,India

  • Pradev Inavolu, MBBS, MD, DM · AIG Hospitals, India

  • Hardik Rughwani, MBBS, MD, DM · AIG Hospitals, India

  • Neeraj Singla, MBBS, MD, DM · AIG Hospitals, India

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2021-12-15
Completion
2022-03-15

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04951739 on ClinicalTrials.gov