Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT05807763

Fundoplication in Laparoscopic PEH Repair Based on FLIP

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Paraesophageal Hernia Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Hernia Hernia, Diaphragmatic Hernia, Hiatal Internal Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NorthShore University HealthSystem, Evanston, Illinois, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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".

Primary outcomes

  1. Number of participants with GERD post-op

    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 outcomes

  1. Number of participants with hernia recurrence

    Time frame: 12 months

    Routine upper GI contrast study and endoscopy will evaluate for hernia recurrence

Sponsors and collaborators

Lead sponsor

The Foundation for Surgical Innovation and Education

Other

Registry information

Official study title

Selective Use of Fundoplication in Laparoscopic Paraesophageal Hernia Repair Based on Intra-operative Impedance Planimetry (FLIP)

Acronym: PEHFLIP

Important dates

Study start
2023
Primary completion
2025
Study completion
2029
First posted
Apr 11, 2023
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.