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Per Oral Endoscopic Myotomy (POEM); comparison of two surgical techniques division all the esophageal muscle layers versus division the inner circular muscle layer of the esophagus only.
Prior to surgery, all patients undergo upper endoscopy , x-ray "time barium" manometry, 24 hours pH registration. Moreover Quality of Life instrument (RAND-36), GSRS (Gastrointestinal Symptom Rating Scale) and a dysphagia score (Eckardt score) are completed by all patients.
Follow-up with surveys 3, 6, 12, and 36 months (GSRS, RAND-36 and Eckardt score).
At 3,12 and 36 months an x-ray "time barium" is performed and after 12 months a gastroscopy and at 24 hours esophageal pH monitoring are performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| total division of the muscle layer | Active Comparator | POEM- total division of the circular muscle layer into the gastroesophageal junction |
|
| partial division of the muscle layer | Active Comparator | POEM - partial division of the circular muscle layer into the gastroesophageal junction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| POEM | Procedure | Peroral endoscopic myotomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients who develop gastroesophageal reflux disease (GERD) | Measured as esophageal acid exposure (pH <4) > 4% of recorded time | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Esophageal emptying function | Measured by Time Barium Swallow X-ray | 1 year |
| Eckardt score | The Eckardt score consists of 4 components including dysphagia, chest pain, regurgitation, and weight loss.Each component is assigned a score from 0 to 3 based on the patient's self-reported response, resulting in a total score that can vary from 0 to 12, higher scores mean a worse outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anders Thorell, Professor | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institutet, Ersta Hospital | Stockholm | Region Stockholm | SE-116 91 | Sweden | ||
| Karolinska Institutet |
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| ID | Term |
|---|---|
| D004931 | Esophageal Achalasia |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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POEM with division all the esophageal muscle layers compared to deviding only the inner circular muscle layer of the esophagus.
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The randomization process is initiated after general anesthesia is induced and the group affiliation will be determined by opening of a sealed envelope specifying the group assignment. The information of group allocation is stored in a closed envelope kept in a locked archive until the study is completed.
| 1 year |
| RAND-36 | The RAND-36 It is comprised of 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. Physical and mental health summary scores are also derived from the eight RAND-36 scales. higher scores mean a better outcome. | 1 year |
| Dysmotility | measured by Manometry | 1 year |
| Gastrointestinal Symptom Rating Scale (GSRS) | Scoring;The questionnaire, which contains 15 items, uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one. A mean value for the items in each dimension should be calculated: Diarrhoea syndrome: 11. Increased passage of stools 12. Loose stools 14. Urgent need for defecation Indigestion syndrome: 6. Borborygmus 7. Abdominal distension 8. Eructation 9. Increased flatus Constipation syndrome: 10. Decreased passage of stools 13. Hard stools 15. Feeling of incomplete evacuation Abdominal pain syndrome: 1. Abdominal pain 4. Sucking sensations 5. Nausea and vomiting Reflux syndrome: 2. Heartburn 3. Acid regurgitation | 1 year |
| Stockholm |
| Stockholm County Council |
| 116 91 |
| Sweden |
| D004066 | Digestive System Diseases |