Achalasia Patient Reported Outcomes

Achalasia Clinical Trial

Official title:

Achalasia Patient Reported Outcomes

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02606578
• Other study ID #: 15-006921
• Status: Terminated
• Start date: October 2015
• Est. completion date: January 15, 2021

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: January 15, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Achalasia
• Achalasia, Esophageal
• Esophageal Achalasia

Intervention

Other:
• Questionnaires
The study team will collect information from your medical record regarding: demographics, operation, nutritional status, laboratory values, testing results, complications, hospital data, cost, length of stay, past medical history and clinical outcomes. At your clinical follow-up visits (~4 weeks, 6 months, and 12 months post operation), a study coordinator will meet with you to assess for adverse events and to have you complete research questionnaires. Alternatively, the study coordinator may call you to assess for adverse events and ask if we can mail you the research questionnaires to complete and mail back. You will also be asked to complete the research questionnaires a minimum of once a year for your lifetime: A study coordinator will call you and ask if we can mail you questionnaires to complete and mail back.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of different surgical techniques with patient reported post-operative symptoms on the achalasia questionnaire	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.	2 years