Achalasia Patient Reported Outcomes

Terminated

• Conditions: Achalasia; Esophageal Achalasia; Achalasia, Esophageal

• Registration Number: NCT02606578
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-11-09
• Study First Submitted QC: 2015-11-13
• Study First Posted: 2015-11-17
• Primary Completion: 2021-01-15
• Study Completion: 2021-01-15
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-21
• Last Update Posted: 2024-03-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of different surgical techniques with patient reported post-operative symptoms on the achalasia questionnaire	2 years	Comparison of surgical techniques evaluated from the patient's medical record using patient reported post-operative symptoms on the achalasia questionnaire. The achalasia questionnaire includes quality of life, pain, activity level, heart burn, acid regurgitation, reflux, dysphagia, and diet.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States