Achalasia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREPOEM
Peroral endoscopic myotomy
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
POEM with division all the esophageal muscle layers compared to deviding only the inner circular muscle layer of the esophagus.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed achalasia * the patient should understand the nature and the purpose of the study and give informed consent
Exclusion criteria
* previous surgical treatment of achalasia * inability to understand the contents of or follow the protocol * other pathology as an explanation for the obstruction of the esophageal transition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients who develop gastroesophageal reflux disease (GERD) | 1 year | Measured as esophageal acid exposure (pH \<4) \> 4% of recorded time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Esophageal emptying function | 1 year | Measured by Time Barium Swallow X-ray |
| Eckardt score | 1 year | 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. |
| RAND-36 | 1 year | 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. |
| Dysmotility | 1 year | measured by Manometry |
| Gastrointestinal Symptom Rating Scale (GSRS) | 1 year | 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 |
Countries
Sweden
Outcome results
None listed