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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • per-oral endoscopic myotomy

    Procedure/Surgery

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: short POEM groupExperimental treatment 1 intervention
Group B: long POEM groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

change from baseline eckardt score at 3 months

the eckardt score is a clinical grading for achalasia evaluating four symtoms dysphagia , regurgitation , retrosternal pain and weight loss ( each scored 0to3 , total score ranges from 0 to 12 where higher scores indicate severe symtoms

Time frame
3 months postoperatively
2

postoperative barium column height at 3 months

evaluation of esophageal emptying by measuring the height of timed barium in centimeters at 1,2and 5 minutes during the barium swallow

Time frame
3 month postoperatively
3

total operative operation

total time taken to complete the procedure , measured in minutes from initial mucosal incision to final closure

Time frame
during the operation (from incision to closure )
4

incidence of intraoperative adverse events

number of participants who experience intraoperative complications such as mucosal perforation or significant hemorrhage during submucosal tunneling

Time frame
during the operation

Secondary outcomes

1

length of hospital stay

total number of days spent in the hospital , calculatef from day of the procedure until the day of official hospital discharge

Time frame
from day of the procedure until the day of official hospital discharge
2

incidence of post-operative reflux esophagitis

the percentage of participants diagnosed with gastresophageal reflux disease ( GERD)evaluated via upper gastrointestinal endoscopy and graded according to los angelos(LA) classification system (grades A to D , where higher grades indicate more severe mucosal breaks

Time frame
3 months postoperatively

Other outcomes

Sponsors and contacts

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