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NOT YET RECRUITING
NCT07686471
NA

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

Sponsor: Assiut University

View on ClinicalTrials.gov

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

Official title: Short Versus Long Submucosal Tunneling in Per-oral Endoscopic Myotomy (POEM) for Type II Achalasia: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-06-28

Completion Date

2028-12-16

Last Updated

2026-07-07

Healthy Volunteers

No

Interventions

PROCEDURE

per-oral endoscopic myotomy

Per-oral endoscopic myotomy (POEM) will be performed under general anesthesia. The procedure involves four main steps: (1) mucosal incision to gain entry to the submucosal space; (2) creation of a submucosal tunnel extending down to the esophagogastric junction; (3) endoscopic myotomy of the circular muscle layer, where the longitudinal length of the myotomy (short vs. long) is determined strictly by the patient's randomized group assignment; and (4) closure of the mucosal entry site using endoscopic clips.

Locations (1)

Assiut university hosoital

Asyut, Egypt