MedTrace Logo

Fundoplication in Laparoscopic PEH Repair Based on FLIP

NCT05807763 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2024-11-27

No results posted yet for this study

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.

Conditions

  • Paraesophageal Hernia

Interventions

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".

Sponsors & Collaborators

  • The Foundation for Surgical Innovation and Education

    lead OTHER

Principal Investigators

  • Christy M Dunst, MD · The Oregon Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-22
Primary Completion
2025-02-22
Completion
2029-02-22

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05807763 on ClinicalTrials.gov