search
Back to results

Fundoplication in Laparoscopic PEH Repair Based on FLIP (PEHFLIP)

Primary Purpose

Paraesophageal Hernia

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laparoscopic paraesophageal hernia repair without fundoplication
Sponsored by
The Foundation for Surgical Innovation and Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paraesophageal Hernia focused on measuring Paraesophageal hernia repair, Laparoscopic paraesophageal hernia repair, PEH repair, Lap PEH repair, FLIP, Functional luminal imaging probe, GERD, Gastroesophageal Reflux Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • NorthShore University HealthSystem
  • Providence Portland Medical Center / The Oregon Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Study Group

Arm Description

Fundoplication

No Fundoplication

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
March 29, 2023
Last Updated
March 29, 2023
Sponsor
The Foundation for Surgical Innovation and Education
search

1. Study Identification

Unique Protocol Identification Number
NCT05807763
Brief Title
Fundoplication in Laparoscopic PEH Repair Based on FLIP
Acronym
PEHFLIP
Official Title
Selective Use of Fundoplication in Laparoscopic Paraesophageal Hernia Repair Based on Intra-operative Impedance Planimetry (FLIP)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 22, 2023 (Actual)
Primary Completion Date
February 22, 2024 (Anticipated)
Study Completion Date
February 22, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Foundation for Surgical Innovation and Education

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paraesophageal Hernia
Keywords
Paraesophageal hernia repair, Laparoscopic paraesophageal hernia repair, PEH repair, Lap PEH repair, FLIP, Functional luminal imaging probe, GERD, Gastroesophageal Reflux Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Fundoplication
Arm Title
Study Group
Arm Type
Experimental
Arm Description
No Fundoplication
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic paraesophageal hernia repair without fundoplication
Intervention Description
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 Outcome Measure Information:
Title
GERD
Description
Patients will undergo endoscopic evaluation and 48 hour pH testing to determine the incidence of objective GERD with and without fundoplication after PEH repair.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
hernia recurrence
Description
Routine upper GI contrast study and endoscopy will evaluate for hernia recurrence
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christy M Dunst, MD
Organizational Affiliation
The Oregon Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
NorthShore University HealthSystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Providence Portland Medical Center / The Oregon Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25868406
Citation
Muller-Stich BP, Achtstatter V, Diener MK, Gondan M, Warschkow R, Marra F, Zerz A, Gutt CN, Buchler MW, Linke GR. Repair of Paraesophageal Hiatal Hernias-Is a Fundoplication Needed? A Randomized Controlled Pilot Trial. J Am Coll Surg. 2015 Aug;221(2):602-10. doi: 10.1016/j.jamcollsurg.2015.03.003. Epub 2015 Mar 14.
Results Reference
background
PubMed Identifier
32556758
Citation
Su B, Dunst C, Gould J, Jobe B, Severson P, Newhams K, Sachs A, Ujiki M. Experience-based expert consensus on the intra-operative usage of the Endoflip impedance planimetry system. Surg Endosc. 2021 Jun;35(6):2731-2742. doi: 10.1007/s00464-020-07704-3. Epub 2020 Jun 16.
Results Reference
background
PubMed Identifier
35972160
Citation
Wu H, Attaar M, Wong HJ, Campbell M, Kuchta K, Denham EW 3rd, Linn J, Ujiki MB. Impedance Planimetry (Endoflip) and Ideal Distensibility Ranges for Optimal Outcomes after Nissen and Toupet Fundoplication. J Am Coll Surg. 2022 Sep 1;235(3):420-429. doi: 10.1097/XCS.0000000000000273. Epub 2022 Aug 10.
Results Reference
background
Citation
Heard, J, DuPree, C, Ibrahim M, Karumuri J, Osman, H, Jeyarajah, R. Endoflip Driven Paraesophageal Hernia Repair without Fundoplication: Heresy or Good Practice? Abstract accepted for presentation at Society for Surgery of the Alimentary Tract (SSAT) Annual Meeting 2023.
Results Reference
background
PubMed Identifier
22955896
Citation
Rieder E, Swanstrom LL, Perretta S, Lenglinger J, Riegler M, Dunst CM. Intraoperative assessment of esophagogastric junction distensibility during per oral endoscopic myotomy (POEM) for esophageal motility disorders. Surg Endosc. 2013 Feb;27(2):400-5. doi: 10.1007/s00464-012-2484-0. Epub 2012 Sep 6.
Results Reference
background
PubMed Identifier
35505258
Citation
Attaar M, Wong HJ, Wu H, Campbell M, Kuchta K, Denham W, Haggerty S, Linn J, Ujiki MB. Changes in impedance planimetry (EndoFLIP) measurements at follow-up after peroral endoscopic myotomy (POEM). Surg Endosc. 2022 Dec;36(12):9410-9415. doi: 10.1007/s00464-022-09286-8. Epub 2022 May 3.
Results Reference
background
PubMed Identifier
35169878
Citation
Wu H, Attaar M, Wong HJ, Campbell M, Kuchta K, Denham W, Linn J, Ujiki MB. Impedance planimetry (EndoFLIP) after magnetic sphincter augmentation (LINX(R)) compared to fundoplication. Surg Endosc. 2022 Oct;36(10):7709-7716. doi: 10.1007/s00464-022-09128-7. Epub 2022 Feb 15.
Results Reference
background
PubMed Identifier
35838832
Citation
Amundson JR, Wu H, VanDruff V, Campbell M, Kuchta K, Hedberg HM, Ujiki MB. Esophagogastric junction compliance on impedance planimetry (EndoFLIP) following peroral endoscopic myotomy (POEM) predicts improvement in postoperative eckardt score. Surg Endosc. 2023 Feb;37(2):1493-1500. doi: 10.1007/s00464-022-09432-2. Epub 2022 Jul 15.
Results Reference
background

Learn more about this trial

Fundoplication in Laparoscopic PEH Repair Based on FLIP

We'll reach out to this number within 24 hrs