- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02606578
Achalasia Patient Reported Outcomes
March 21, 2024 updated by: Janani S. Reisenauer, Mayo Clinic
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Karlyn Pierson, RN, MAN
- Phone Number: 507-293-0807
- Email: pierson.karlyn@mayo.edu
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55901
- Mayo Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
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
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Janani Reisenauer, MD, Mayo Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (Actual)
January 15, 2021
Study Completion (Actual)
January 15, 2021
Study Registration Dates
First Submitted
November 9, 2015
First Submitted That Met QC Criteria
November 13, 2015
First Posted (Estimated)
November 17, 2015
Study Record Updates
Last Update Posted (Actual)
March 22, 2024
Last Update Submitted That Met QC Criteria
March 21, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-006921
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Achalasia
-
Zeng ChanghaoRecruitingCricopharyngeal AchalasiaTaiwan
-
Copka SonpashanNot yet recruitingCricopharyngeal Achalasia
-
Germans Trias i Pujol HospitalActive, not recruiting
-
Govind Ballabh Pant HospitalActive, not recruitingAchalasia CardiaIndia
-
Asian Institute of Gastroenterology, IndiaUnknown
-
University Hospital, Strasbourg, FranceCompleted
-
Hospices Civils de LyonCompleted
-
Cairo UniversityRecruitingAchalasia | Achalasia CardiaEgypt
-
Federico II UniversityCompleted
-
Asian Institute of Gastroenterology, IndiaCompleted
Clinical Trials on Questionnaires
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH)Completed
-
Direction Centrale du Service de Santé des ArméesCompleted
-
Sun Yat-sen UniversityNot yet recruiting
-
Assistance Publique - Hôpitaux de ParisRecruitingIntensive Care Unit Syndrome | Pediatric Post-intensive Care SyndromeFrance
-
University Hospital, GrenobleUniversity Grenoble AlpsNot yet recruitingChildhood Cancer | Adapted Physical ActivityFrance
-
M.D. Anderson Cancer CenterCompletedAdvanced Cancer | Malignant Neoplasms of Independent (Primary) Multiple SitesUnited States
-
The University of Hong KongCompleted
-
Cliniques universitaires Saint-Luc- Université...Fonds National de la Recherche ScientifiqueNot yet recruitingAlcohol Use Disorder
-
Memorial Sloan Kettering Cancer CenterIcahn School of Medicine at Mount Sinai; Hackensack Meridian Health; Derald H...CompletedLeukemia | Multiple Myeloma | Non-Hodgkin's Lymphoma | Hodgkin's DiseaseUnited States
-
Centre Hospitalier Universitaire DijonCompleted