A Study to Compare Safety and Effectiveness of Transoral Incisionless Fundoplication versus Laparoscopic Partial Fundoplication to Treat Gastroesophageal Reflux Disease Patients with Hiatal Hernia

Overview

About this study

The purpose of this study is to compare treatment effectiveness and safety between Transoral Incisionless Fundoplication (TIF) and Laparoscopic Nissen Fundoplication (LNF) in GERD patients with hiatal hernia undergoing hernia repair.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • 22 - 80 years of age.
  • Subjects have GERD with hiatal hernia < 5 cm, and Hill grade III or IV.
  • Pathologic reflux while off PPI based on Lyon criteria by either of the following:
    • Conclusive evidence for pathologic reflux defined as acid exposure time (AET) > 6% or LA grade C or D esophagitis;
    • Borderline evidence of pathologic reflux defined as presence of one of the following parameters: AET 4-6%, LA grade A or B, and signed informed consent.
  • Commitment to long-term study.
  • Ability to give consent individually or by a legally authorized representative.

Exclusion Criteria:

  • Hiatal hernia > 5 cm.
  • Evidence of a major motility abnormality defined by the Chicago classification version 3.0 (achalasia, absent contractility, esophagogastric junction outflow obstruction, distal esophageal spasm, or hypertensive peristalsis).
  • Pregnancy (in females) at time of procedure.
  • Previous anti-reflux procedure, have contraindications to the procedure will be excluded from participation.
  • Subjects requiring mesh treatment at time of procedure.
  • Provider discretion.
  • BMI > 35.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Barham Abu Dayyeh, M.D., M.P.H.

Open for enrollment

Contact information:

Travis Fisher

(507) 538-7168

fisher.travis1@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20507996

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