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Fundoplication in Laparoscopic PEH Repair Based on FLIP

NCT ID: NCT05807763

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-22

Study Completion Date

2029-02-22

Brief Summary

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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

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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.

Conditions

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Paraesophageal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Group

Fundoplication

Group Type NO_INTERVENTION

No interventions assigned to this group

Study Group

No Fundoplication

Group Type EXPERIMENTAL

Laparoscopic paraesophageal hernia repair without fundoplication

Intervention Type 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".

Interventions

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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".

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Foundation for Surgical Innovation and Education

OTHER

Sponsor Role lead

Responsible Party

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Christy M. Dunst

Program Director Complex GI-Foregut Fellowship, Providence Portland Medical Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christy M Dunst, MD

Role: PRINCIPAL_INVESTIGATOR

The Oregon Clinic

Locations

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NorthShore University HealthSystem

Evanston, Illinois, United States

Site Status

Providence Portland Medical Center / The Oregon Clinic

Portland, Oregon, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 25868406 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32556758 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35972160 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 22955896 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35505258 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35169878 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35838832 (View on PubMed)

Other Identifiers

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STUDY2022000698

Identifier Type: -

Identifier Source: org_study_id