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The aim of this study is to compare the clinical efficacy, safety, and technical outcomes of per-oral endoscopid myotomy( POEM )in treatment-naïve achalasia patients versus patients with previous pneumatic dilation.
Study subjects:
Inclusion criteria: Adult patients diagnosed with achalasia (Chicago classification types I-III by High resolution manometry (HRM) ).
Exclusion criteria:
Children below 18 yr.
Prior surgical myotomy.
pregnancy
Groups:
Group I (Naïve group): Patients undergoing POEM as primary therapy.
Group II (Prior Pneumatic Dilation group): Patients undergoing POEM after failed or relapsed pneumatic dilation.
Data analyzed included the following:
Eckardt score :
It is a 12-point score which is as following :
0 1 2 3 Recent weight loss (kg) none <5 kg 5-10 kg >10 kg Dysphagia none occasional daily each meal Retrosternal chest pain none occasional daily each meal Regurgitation none occasional daily each meal
A score of ≥3 is suggestive of active achalasia.
POEM technique :
Briefly, the procedure included submucosal injection at the 5-6-o'clock position entry point, and mucosal incision at the posterior wall about 8-10 cm above the esophageal-gastric junction (EGJ), entry into the tunnel by clearing submucosal fibers, and then myotomy initiating about 2 cm down from the mucosal incision and extending 2-4 cm into the cardia. Afterwards, the mucosal incision will be closed using endoclips. In special circumstances, when fibrosis or adhesions present because of prior PD, the myotomy will be located in an area of normal (fibrosis-free) tissue, and a long myotomy will be made.
Technical success was defined as a successful completion of the entire POEM procedure. Clinical success was defined as a post-POEM Eckardt score of 3.
Research outcome measures:
Primary (main):
Clinical success at 3 and 6 months (Eckardt score ≤ 3 )
Secondary (subsidiary):
Technical success
Procedure time
Intra- and post-operative complications.
Data management and analysis :
Data will be collected first in sheets, and then will be in Master sheet. Data of every patient will be coded. This will be done using SPSS. Categorical data were presented as number and percentage. Continuous data is presented as mean and standard deviation (SD) if normally distributed or median and interquartile range (IQR) if non normal distributed. Other test will be used according to the results and relations needed to be studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (Naïve group): Patients undergoing POEM as primary therapy. | Active Comparator |
| |
| - Group II (Prior Pneumatic Dilation group):Patients undergoing POEM after failed pneumatic dilation | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| per-oral endoscopic myotomy (POEM) | Procedure | Briefly, the procedure included submucosal injection at the 5-6-o'clock position entry point, and mucosal incision at the posterior wall about 8-10 cm above the esophageal-gastric junction (EGJ), entry into the tunnel by clearing submucosal fibers, and then myotomy initiating about 2 cm down from the mucosal incision and extending 2-4 cm into the cardia. Afterwards, the mucosal incision will be closed using endoclips. In special circumstances, when fibrosis or adhesions present because of prior PD, the myotomy will be located in an area of normal (fibrosis-free) tissue, and a long myotomy will be made. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical success at 3 and 6 months (Eckardt score ≤ 3 ) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| - Technical success | the procedure will be done completely or need to do premature myotomy or to be aborted due to fibrosis or any technical problem | 1 day ( the day of the procedure ) |
| procedure time |
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Inclusion Criteria:
Exclusion Criteria:
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randomized control trial
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|
compare the procedure time between the 2 groups
| 1 day ( the day of the procedure) |
| Intraoperative & post operative complications | define intraoperative complications ( pneumoperitoneum, pneumothorax , mucosal perforation or bleeding ) and post operative complications ( Infections,esophageal leak ,subcutaneous emphysema, GERD,esophagitis ) and compare these complications between the 2 gruops. | up to 6 months after the procedure |
| ID | Term |
|---|---|
| D004931 | Esophageal Achalasia |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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