Achalasia Patient Reported Outcomes

NCT02606578 | Terminated DMC

• 1 other identifier: 15-006921
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Achalasia; Achalasia; Achalasia, Esophageal

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Questionnaires OTHER

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.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \>18 years old
• Undergoing a POEM or laparoscopic modified heller myotomy and anti-reflux procedures
• Esophagus diameter less \<8 cm on barium swallow test

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55901, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Esophageal Achalasia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Janani Reisenauer, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 9, 2015
• First Posted: November 17, 2015
• Study Start: October 1, 2015
• Primary Completion: January 15, 2021
• Study Completion: January 15, 2021
• Last Updated: March 22, 2024

Record last verified: 2024-03

Locations

US (1)