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Achalasia Patient Reported Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02606578
Recruitment Status : Recruiting
First Posted : November 17, 2015
Last Update Posted : September 30, 2022
Sponsor:
Information provided by (Responsible Party):
Shanda Blackmon, M.D., M.P.H., Mayo Clinic

Study Description
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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.

Condition or disease Intervention/treatment
Esophageal Achalasia Achalasia Achalasia, Esophageal Other: Questionnaires

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 Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Achalasia Patient Reported Outcomes
Study Start Date : October 2015
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • 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.


Outcome Measures
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Primary Outcome Measures :
  1. Comparison of different surgical techniques with patient reported post-operative symptoms on the achalasia questionnaire [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02606578


Contacts
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Contact: Karlyn Pierson, RN, MAN 507-293-0807 pierson.karlyn@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55901
Contact: Karlyn Pierson, MAN, RN    507-293-0807    pierson.karlyn@mayo.edu   
Principal Investigator: Shanda Blackmon, MD, MPH, FACS         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Shanda Blackmon, MD, MPH, FACS Mayo Clinic
More Information
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Responsible Party: Shanda Blackmon, M.D., M.P.H., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02606578    
Other Study ID Numbers: 15-006921
First Posted: November 17, 2015    Key Record Dates
Last Update Posted: September 30, 2022
Last Verified: September 2022
Additional relevant MeSH terms:
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Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases