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

NCT07686471 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-07-07

No results posted yet for this study

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

Conditions

  • Esophageal Achalasia

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.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Omar M Magdy, master dgree · Assiut university hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-28
Primary Completion
2028-06-16
Completion
2028-12-16

Countries

  • Egypt

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 NCT07686471 on ClinicalTrials.gov