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Not Yet Recruiting NCT07686471

Short Versus Long Submucosal Tunneling in Per-oral Endoscopic Myotomy (POEM) for Type II Achalasia.

Conditions: Esophageal Achalasia

Sex: All
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: Assiut University

Location: Assiut university hosoital Asyut

Summary

this study is prospective , randomized and interventional ,will be performed on 50 patients to compare the clinical utility , safety profile and postoperative recovery metrics between short and long per-oral endoscopic myotomy , patients will be divided randomly into two equal groups one will do short myotomy and the other group will do long myotomy , each group will contain 25 patients methodology \&patient selection : patients follow the inclusion criterias including : * Patients of all ages were eligible for inclusion in the study with no upper or lower age limits applied . * Both sexes are included . * Type II achalasia patients who are diagnosed by High Resolution. Manometry based on Chicago Classification (v4.0) characterized by (failed esophageal peristalsis , pan-esophageal pressurization in ≥20% of swallows and Integrated Relaxation Pressure (IRP) \>15 mmHg ). * Eckardt score \>3 ( moderate to severe symptoms). this study aims to compare the outcomes of short versus long esophageal myotomy in cases with type II achalasia using Eckardt score and barium study at 3 month follow up. also to evaluate difference in length of the opearation , intra-operative and post-operative adverse events between short and long submucosal tunneling. every patient will do upper endoscopy and manometry preoperative , also ekcardt score will be caculated , follow up after 3 months by barium swallow and eckardt score

Eligibility Criteria

Inclusion Criteria: * Patients of all ages were eligible for inclusion in the study with no upper or lower age limits applied . * Both sexes are included . * Type II achalasia patients who are diagnosed by High Resolution. Manometry based on Chicago Classification (v4.0) characterized by (failed esophageal peristalsis , pan-esophageal pressurization in ≥20% of swallows and Integrated Relaxation Pressure (IRP) \>15 mmHg ). * Eckardt score \>3 ( moderate to severe symptoms Exclusion Criteria: * Type I ,type III achalasia \& Non-achalasia spastic motility disorders. * Sigmoid type esophagus (diameter\> 6 cm ). * Esophageal diverticulae . * Presence of large Hiatus Hernia ( \>5cm). * Severe erosive esophagitis (La Grade C or D) or Barrett's Esophagus. * History of previous Heller's myotomy. * Pseudoachalasia due to underlying malignancy. * Severe coagulopathy ( INR\>1.5 or platelets \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07686471). StuddyBuddy aggregates publicly available trial information.