Achalasia Patient Reported Outcomes
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 19 - Any |
| Updated: | 1/11/2019 |
| Start Date: | October 2015 |
| End Date: | October 2020 |
| Contact: | Karlyn Pierson, RN, MAN |
| Email: | pierson.karlyn@mayo.edu |
| Phone: | 507-538-1960 |
Patients that are either scheduled to undergo or have undergone an achalasia procedure at the
Mayo Clinic Rochester are asked to participate. The purpose of this study is to gather
information and determine if one of these procedures is superior to the other.
Mayo Clinic Rochester are asked to participate. The purpose of this study is to gather
information and determine if one of these procedures is superior to the other.
This is a non-randomized, non-inferiority trial that has been created to compare results of
achalasia procedures including but not limited to: POEM + Partial Fundoplication (PF), POEM
and Laparoscopic Modified Heller Myotomy + PF and POEM + Peroral Plication of the esophagus.
Using a set of consistent evaluation tools for patients undergoing treatment for achalasia
allows a standardized evaluation and comparison of these groups of patients. The long term
and comparative POEM procedure outcomes are not currently known. Patients undergoing POEM,
fundoplication, and/or laparoscopic myotomy report having varying degrees of symptoms of
reflux, dysphagia, and pain. Providers also note varying degrees of esophagitis by endoscopy,
reflux by impedance or pH scoring, and recurrence by repeat manometry. Many of these issues
can be quantified using pH probe testing, upper GI endoscopy, high resolution manometry, CT
scans, Endoflip device and esophagrams. There are various validated questionnaires that have
been used to assess problem areas of reflux, dysphagia, and pain such as the Promis Global
Health Score, Ekhardt Score, Mayo GER Score, Modified Dysphagia Questionnaire-30 Day, Zubrod
Score, and pain scale. Each of these symptoms, tests, and questionnaires contributes to the
provider's understanding of the patient's postoperative outcome.
achalasia procedures including but not limited to: POEM + Partial Fundoplication (PF), POEM
and Laparoscopic Modified Heller Myotomy + PF and POEM + Peroral Plication of the esophagus.
Using a set of consistent evaluation tools for patients undergoing treatment for achalasia
allows a standardized evaluation and comparison of these groups of patients. The long term
and comparative POEM procedure outcomes are not currently known. Patients undergoing POEM,
fundoplication, and/or laparoscopic myotomy report having varying degrees of symptoms of
reflux, dysphagia, and pain. Providers also note varying degrees of esophagitis by endoscopy,
reflux by impedance or pH scoring, and recurrence by repeat manometry. Many of these issues
can be quantified using pH probe testing, upper GI endoscopy, high resolution manometry, CT
scans, Endoflip device and esophagrams. There are various validated questionnaires that have
been used to assess problem areas of reflux, dysphagia, and pain such as the Promis Global
Health Score, Ekhardt Score, Mayo GER Score, Modified Dysphagia Questionnaire-30 Day, Zubrod
Score, and pain scale. Each of these symptoms, tests, and questionnaires contributes to the
provider's understanding of the patient's postoperative outcome.
Inclusion Criteria:
- >18 years old
- Undergoing a POEM or laparoscopic modified heller myotomy and anti-reflux procedures
- Esophagus diameter less <8 cm on barium swallow test
Exclusion Criteria:
- Pregnant
- Diverticular disease of the esophagus
- Barrett's esophagus
- Extensive abdominal adhesions
- <50% predicted FEV1 on pulmonary function testing
- Cardiac ejection fraction <25%
- Esophageal stricture from prior myotomy
- Sigmoidization of the esophagus
- More than one prior balloon dilation (>3 cm) or any prior dilation of 3 cm
We found this trial at
1
site
Rochester, Minnesota 55905
Principal Investigator: Shanda Blackmon, MD, MPH, FACS
Phone: 507-538-1960
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