Achalasia
Conditions
Keywords
POPE
Brief summary
Researchers are reviewing and analyzing surgical and clinical outcomes of subjects who underwent POPE for end-stage achalasia, a sigmoid esophagus, or a redundant conduit that has been used to replace the esophagus. This data will help researchers determine the safety and efficacy of a novel minimally invasive treatment compared to invasive surgery.
Detailed description
Researchers will be collecting electronic medical data for subjects who have already undergone Per-oral Plication of the Esophagus (POPE) procedure. Subject characteristics, radiographic documentation, videos, procedural details, and subject reported outcomes would be collected. This data will be used for review and analysis to answer questions aimed in this study. Data collected from this study will be entered into a database that will be maintained for future research.
Interventions
PROCEDUREPOPE
Patients who have undergone Per-oral Plication of the Esophagus (POPE) procedure.
Sponsors
Mayo Clinic
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults \> 18 years of age * Patients who have already undergone Per-oral Plication of the Esophagus (POPE) procedure
Exclusion criteria
* Patients \<18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 01/01/2017-9/17/2018 | Evaluate safety by assessment of adverse events of the novel minimally invasive treatment compared to invasive surgery. |
| Patient Reported Outcomes using the CONDUIT patient questionnaire. | 01/01/2017-9/17/2018 | Evaluate efficacy by reviewing patient reported outcomes of the novel minimally invasive treatment compared to invasive surgery. |
Countries
United States
Outcome results
None listed