Achalasia
Conditions
Keywords
dysphagia
Brief summary
This study is to evaluate outcomes of a less invasive surgical procedure for the treatment of achalasia.
Detailed description
This study will assess the feasibility and efficacy of a novel endoscopic procedure, Per-oral Endoscopic Esophagomyotomy (POEM)in treating patients with achalasia.
Interventions
PROCEDUREPer-oral Endoscopic Esophagomyotomy (POEM)
The surgeon is cutting only through the innermost layers of muscles in the esophagus down to the stomach, leaving the outer layer intact.
Sponsors
University Hospitals Cleveland Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* o Subjects with a manometric/radiologic diagnosis of primary achalasia; EGD shows no neoplasm * Ability to undergo general anesthesia * The subject is \> 18 yrs.of age * Ability to give informed consent
Exclusion criteria
* o Sigmoid achalasia * Contraindicated for EGD * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The success of the POEM procedure is measured by improved symptoms as compared to pre-op, including the ability to swallow with low incidence of GERD and significantly reduced resting LES pressure | Within the first 3 months after surgery | Will assess the outcomes and efficacy of the endoscopic procedure, Per-oral Endoscopic Esophagomyotomy(POEM)in the treatment of achalasia. The patient will be assessed for improvement of their swallowing as assessed on the repeat time barium swallow and increase oral intake without nausea and vomiting. |
Countries
United States
Outcome results
None listed