Fundoplication in Laparoscopic PEH Repair Based on FLIP

Part of paid clinical trials in Evanston, Illinois.

Sponsor
The Foundation for Surgical Innovation and Education
Study ID
NCT05807763
Status
Enrolling By Invitation

Conditions

  • Paraesophageal Hernia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Laparoscopic paraesophageal hernia repair without fundoplication — PROCEDURE
    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".

Study Details

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.

Key Dates

Start date
Feb 22, 2023
Status verified
Apr 2024
Primary completion
Feb 22, 2025
Completion
Feb 22, 2029

Study Design

Enrollment
260 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Control Group
    Fundoplication
  • Experimental: Study Group
    No Fundoplication

Primary Outcome Measure

Number of participants with GERD post-op [ Time Frame: 12 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
NorthShore University HealthSystemEvanstonIllinois60201-
Providence Portland Medical Center / The Oregon ClinicPortlandOregon97213-

Find similar trials in Evanston, IL

By research site
NorthShore University HealthSystem· Evanston, ILProvidence Portland Medical Center / The Oregon Clinic· Portland, OR

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