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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorAssiut University

About this trial

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

Qualifiers

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

Disqualifiers

Type I ,type III achalasia & Non-achalasia spastic motility disorders.

Sigmoid type esophagus (diameter> 6 cm ).

Esophageal diverticulae .

Presence of large Hiatus Hernia ( >5cm).

Trial design

Treatments tested in this trial

  • per-oral endoscopic myotomy

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators