Fundoplication in Laparoscopic PEH Repair Based on FLIP

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

Status

Enrolling by invitation

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05807763

Acronym

PEHFLIP

Enrollment

260

Registered

2023-04-11

Start date

2023-02-22

Completion date

2029-02-22

Last updated

2024-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paraesophageal Hernia

Keywords

Paraesophageal hernia repair, Laparoscopic paraesophageal hernia repair, PEH repair, Lap PEH repair, FLIP, Functional luminal imaging probe, GERD, Gastroesophageal Reflux Disease

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.

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.

Interventions

PROCEDURELaparoscopic 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with GERD post-op	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

Measure	Time frame	Description
Number of participants with hernia recurrence	12 months	Routine upper GI contrast study and endoscopy will evaluate for hernia recurrence

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026