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Fundoplication in Laparoscopic PEH Repair Based on FLIP (PEHFLIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05807763
Recruitment Status : Enrolling by invitation
First Posted : April 11, 2023
Last Update Posted : April 11, 2023
Sponsor:
Information provided by (Responsible Party):
Christy M. Dunst, The Oregon Clinic

Study Description
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Brief Summary:
Prospective randomized controlled trial to identify a sub-set of patients that do not benefit from the routine addition, and added morbidity, of a fundoplication during laparoscopic paraesophageal hernia repair.

Condition or disease Intervention/treatment Phase
Paraesophageal Hernia Procedure: Laparoscopic paraesophageal hernia repair without fundoplication Not Applicable

Detailed Description:
Prospective Randomized Controlled Trial in which patients who meet criteria will be randomized to receive a concurrent fundoplication or no fundoplication at the time of paraesophageal hernia repair. Patients with known objective gastroesophageal reflux disease prior to surgery, those found to have a short esophagus in the operating room or defective gastroesophageal reflux barrier by intra-operative impedance planimetry measurements and/or endoscopic valve grade will be excluded.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Selective Use of Fundoplication in Laparoscopic Paraesophageal Hernia Repair Based on Intra-operative Impedance Planimetry (FLIP)
Actual Study Start Date : February 22, 2023
Estimated Primary Completion Date : February 22, 2024
Estimated Study Completion Date : February 22, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control Group
Fundoplication
Experimental: Study Group
No Fundoplication
 Procedure: Laparoscopic paraesophageal hernia repair without fundoplication
Patients undergoing laparoscopic paraesophageal hernia repair will be evaluated for risk of esophageal reflux using intra-operative impedance planimetry and endoscopic gastroesophageal valve grade. Patients deemed low risk for esophageal reflux will then be randomized to "partial fundoplication" or "no fundoplication".


Outcome Measures
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Primary Outcome Measures :
  1. GERD [ Time Frame: 12 months ]
    Patients will undergo endoscopic evaluation and 48 hour pH testing to determine the incidence of objective GERD with and without fundoplication after PEH repair.


Secondary Outcome Measures :
  1. hernia recurrence [ Time Frame: 12 months ]
    Routine upper GI contrast study and endoscopy will evaluate for hernia recurrence


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients undergoing laparoscopic paraesophageal hernia repair

Exclusion Criteria:

  • History of a prior hiatal hernia/paraesophageal hernia repair
  • Patients with objective GERD preoperatively
  • Intra-operative short esophagus
  • Defective gastroesophageal reflux barrier as determined by impedance planimetry (FLIP)
  • Defective gastroesophageal reflux barrier as determined by intra-operative endoscopy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05807763


Locations
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United States, Illinois
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
United States, Oregon
Providence Portland Medical Center / The Oregon Clinic
Portland, Oregon, United States, 97213
Sponsors and Collaborators
The Foundation for Surgical Innovation and Education
Investigators
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Principal Investigator: Christy M Dunst, MD The Oregon Clinic
More Information
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Publications:
Heard, J, DuPree, C, Ibrahim M, Karumuri J, Osman, H, Jeyarajah, R. Endoflip Driven Paraesophageal Hernia Repair without Fundoplication: Heresy or Good Practice? Abstract accepted for presentation at Society for Surgery of the Alimentary Tract (SSAT) Annual Meeting 2023.

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Responsible Party: Christy M. Dunst, Program Director Complex GI-Foregut Fellowship, Providence Portland Medical Center, The Oregon Clinic
ClinicalTrials.gov Identifier: NCT05807763    
Other Study ID Numbers: STUDY2022000698
First Posted: April 11, 2023    Key Record Dates
Last Update Posted: April 11, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christy M. Dunst, The Oregon Clinic:
Paraesophageal hernia repair
Laparoscopic paraesophageal hernia repair
PEH repair
Lap PEH repair
 FLIP
Functional luminal imaging probe
GERD
Gastroesophageal Reflux Disease
Additional relevant MeSH terms:
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Hernia
Hernia, Hiatal
Pathological Conditions, Anatomical
Hernia, Diaphragmatic
Internal Hernia