PEHFLIP: Fundoplication in Laparoscopic PEH Repair Based on FLIP

Sponsor

The Foundation for Surgical Innovation and Education (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05807763

Collaborator

(none)

260

Enrollment

Locations

Arms

Anticipated Duration (Months)

130

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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 :

Feb 22, 2023

Anticipated Primary Completion Date :

Feb 22, 2024

Anticipated Study Completion Date :

Feb 22, 2029

Arms and Interventions

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".

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

Primary Outcome Measures

GERD [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

hernia recurrence [12 months]
Routine upper GI contrast study and endoscopy will evaluate for hernia recurrence

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NorthShore University HealthSystem	Evanston	Illinois	United States	60201
2	Providence Portland Medical Center / The Oregon Clinic	Portland	Oregon	United States	97213