RECRUITING

Esophagogastric Junction Distensibility During Hiatal Hernia Repair

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The investigators aim to ascertain the effects of hiatal hernia repair and fundoplication on the distensibility of the esophagogastric junction (EGJ) as measured by FLIP topography/impedance planimetry. The investigators also aim to assess for any correlation between values of EGJ distensibility and GERD related quality of life (QOL) and dysphagia scores.

Official Title

Esophagogastric Junction Distensibility During Hiatal Hernia Repair

Quick Facts

Study Start:2020-09-28
Study Completion:2025-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04450628

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient undergoing hiatal hernia repair (types I-IV included) and fundoplication
  2. * Absence of spastic esophageal disorders (i.e. jackhammer esophagus, achalasia types I-III) assessed by preoperative high-resolution manometry
  3. * Adult patients ≥18 years
  4. * Elective repairs
  1. * Redo hiatal hernia repairs
  2. * Emergent repairs
  3. * Patients with contraindication to surgery or endoscopy
  4. * Patients with esophageal varices
  5. * Cases with insufficient esophageal length in which fundoplication is unable to be performed or a Collis gastroplasty is required
  6. * Connective tissue diseases such as scleroderma or lupus
  7. * Diameter measurements less than 5 mm as the EF-325N catheter is not suitable

Contacts and Locations

Study Contact

Greg T Scarola, MS
CONTACT
704-355-5379
Gregory.Scarola@atriumhealth.org

Principal Investigator

Paul D Colavita, MD
PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences

Study Locations (Sites)

Atrium Health - Carolinas Medical Center
Charlotte, North Carolina, 28203
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • Paul D Colavita, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

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 Registration Dates

Study Start Date2020-09-28
Study Completion Date2025-08

Study Record Updates

Study Start Date2020-09-28
Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

  • EndoFLIP
  • Distensibility of the esophagogastric junction
  • Gastroesophageal Reflux Disease-Health Related Quality of Life survey
  • Mayo Dysphagia Questionnaire

Additional Relevant MeSH Terms

  • Esophagogastric Junction Distensibility
  • Hiatal Hernia