Active — Not RecruitingNot Applicable

Esophagogastric Junction Distensibility During Hiatal Hernia Repair

United States25 participantsStarted 2020-09-28

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient undergoing hiatal hernia repair (types I-IV included) and fundoplication * Absence of spastic esophageal disorders (i.e. jackhammer esophagus, achalasia types I-III) assessed by preoperative high-resolution manometry * Adult patients ≥18 years * Elective repairs Exclusion Criteria: * Redo hiatal hernia repairs * Emergent repairs * Patients with contraindication to surgery or endoscopy * Patients with esophageal varices * Cases with insufficient esophageal length in which fundoplication is unable to be performed or a Collis gastroplasty is required * Connective tissue diseases such as scleroderma or lupus * Diameter measurements less than 5 mm as the EF-325N catheter is not suitable

What they're measuring

Change in distensibility index

Timeframe: Baseline to day 1

Trial details

NCT IDNCT04450628

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-02

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