Clinical trial NCT02606578: Achalasia Patient Reported Outcomes
Official title: Achalasia Patient Reported Outcomes
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Esophageal Achalasia
Achalasia
Achalasia, Esophageal
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-11-17
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing PerOral Endoscopic Myotomy (POEM) or Laparoscopic Modified Heller Myotomy and Anti-Reflux Procedures at Mayo Clinic Rochester

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of different surgical techniques with patient reported post-operative symptoms on the achalasia questionnaire
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Janani Reisenauer, MD
role: PRINCIPAL_INVESTIGATOR
References: