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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
350
Patients will receive the surgical procedure described in the summary (POEM).
Surgical procedure
The Oregon Clinic
Portland, Oregon, United States
Improved quality of life as defined by survey pre and post surgery
patients diagnosed with achalasia will be given a quality of life survey before surgery and again six months after surgery.
Time frame: six months
Negative pH test
Patients will be required to have 24 hour pH testing after surgery.
Time frame: six months
Bleeding
recorded blood loss will be taken during surgery.
Time frame: 1 year
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