Achalasia
Conditions
Keywords
Achalasia
Brief summary
This is a study of the safety and efficacy of a new surgical procedure using endoscopic instruments and a tunneling technique to reach the LES for dissection. We hypothesize that this technique provides an incisionless, less invasive option with similar functional outcome compared to standard Heller myotomy.
Detailed description
By the endoscopic creation of an esophageal submucosal tunnel the inner circular muscle layer can be easily visualized. In contrast to conventional Heller myotomy, the dissection of only the inner circular esophageal muscle layer leaves the outer longitudinal muscle layer intact. Thereby, post-interventional reflux disease should be avoided.
Interventions
PROCEDUREEndoscopic Myotomy
Patients will receive the surgical procedure described in the summary (POEM).
PROCEDUREEndoscopic Myotomy for treatment of achalasia
Surgical procedure
Sponsors
The Oregon Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Ability to undergo general anesthesia * Age \> 18 yrs. of age and \< 85 yrs. of age * Ability to give informed consent * Candidate for elective Heller myotomy
Exclusion criteria
* Previous mediastinal or esophageal surgery * Contraindications for esophagogastroduodenoscopy * BMI \> 45
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improved quality of life as defined by survey pre and post surgery | six months | patients diagnosed with achalasia will be given a quality of life survey before surgery and again six months after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Negative pH test | six months | Patients will be required to have 24 hour pH testing after surgery. |
| Bleeding | 1 year | recorded blood loss will be taken during surgery. |
Countries
United States
Outcome results
None listed