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