An observational study in Zenker Diverticulum, Progressive Dysphagia and Pharyngoesophageal Diverticulum, sponsored by University of Cincinnati. Recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-09-13.
Sponsored by University of Cincinnati · Observational
Patients undergoing open transcervical or endoscopic approach in which a laser or stapler is used to divide the common wall between the diverticulum and esophagus, or who are not surgical candidates but agree to follow-up.
A prospective, multi-institutional study comparing the effectiveness of the above procedures will provide a large cohort using standardized diagnostic studies, diverticulum size measurements, treatment approaches, pre-operative and post-operative assessment of symptoms in order to both compare the effectiveness of the procedures and to stratify the patients in order to determine whether demographics such as age, pre-operative size, and/or peri-operative co-morbidities influence outcomes.
No intended gender or racial/ethnic distribution. Intended age range is 18-100 years of age. The vulnerable population (patients) will be protected from potential coercion or undue influence as this is an observational study with elective participation in follow-up patient surveys in which patient data will otherwise be deidentified upon inspection
Exclusion Criteria:
The goal of the project is to perform the first prospective, multi-institutional long-term (5 year) study comparing the outcomes of open, transcervical versus rigid endoscopic treatment of cervical esophageal diverticulum and cricopharyngeal dysfunction in resolving associated symptoms, complications, and recurrence rates of dysphagia surgery. This study will also include cricopharyngeal bar as it pertains to an early Zenker's diverticulum.
Also known as: observation
Add to the paucity of dysphagia outcomes data after surgical treatment of Zenker's diverticulum.
Demographic data will be summarized for categorical and continuous measures. Continuous data will be compared between groups using student's t-test.
Time frame: 5 years
Include dysphagia outcomes comparing both endoscopic and open repair of Zenker's diverticulum to develop preliminary evidence-based indications and long-term outcomes, exploring various relevant subset analyses.
Would standardize the above data and lend increased power due to its multi-institutional nature. The post-operative data will include the following surveys EAT-10, RSI, VHI in order to assess for post-operative resolution of symptoms as well as an esophagram at 12month
Time frame: 5 years
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