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Paraesophageal HerniaPEHFLIPNCT05807763

Fundoplication in Laparoscopic PEH Repair Based on FLIP

A study testing Laparoscopic paraesophageal hernia repair without fundoplication in people with Paraesophageal Hernia, run by The Foundation for Surgical Innovation and Education at 2 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Paraesophageal Hernia
What is being tested?
Laparoscopic paraesophageal hernia repair without fundoplication
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
2 sitesUnited States
Study dates
22 Feb 2023to 22 Feb 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients undergoing laparoscopic paraesophageal hernia repair

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites

  • NorthShore University HealthSystem

    Evanston, Illinois, 60201

  • Providence Portland Medical Center / The Oregon Clinic

    Portland, Oregon, 97213

Other trials in United States

About this study

Official title: Selective Use of Fundoplication in Laparoscopic Paraesophageal Hernia Repair Based on Intra-operative Impedance Planimetry (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.

Read the 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.

Being tested
Laparoscopic paraesophageal hernia repair without fundoplication
Keywords
Paraesophageal hernia repair, Laparoscopic paraesophageal hernia repair, PEH repair, Lap PEH repair, FLIP, Functional luminal imaging probe, GERD, Gastroesophageal Reflux Disease
Medical subject headings
Hernia, Hiatal, Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparoscopic paraesophageal hernia repair without fundoplicationProcedure or surgery

    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 groups in NCT05807763
Study groupRoleWhat they receive
Control GroupNo interventionFundoplication
Study GroupExperimentalNo Fundoplication
Receives: Procedure: Laparoscopic paraesophageal hernia repair without fundoplication

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with GERD post-op

    Patients will undergo endoscopic evaluation and 48 hour pH testing to determine the incidence of objective GERD with and without fundoplication after PEH repair.

    Measured: 12 months

Secondary outcomes (1)

  1. Number of participants with hernia recurrence

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2023
  2. Study start22 Feb 2023
  3. Primary completion22 Feb 2025 (estimated)
  4. Study completion22 Feb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05807763
Sponsor's protocol ID
STUDY2022000698
Acronym
PEHFLIP
Status last verified
Apr 2024
First submitted
29 Mar 2023
Last updated
27 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25868406

  • 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.

    PubMed 32556758

  • 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.

    PubMed 35972160

  • 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.

  • 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.

    PubMed 22955896

  • 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.

    PubMed 35505258

  • 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.

    PubMed 35169878

  • 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.

    PubMed 35838832

Questions about this trial

What is this clinical trial studying?

A study testing Laparoscopic paraesophageal hernia repair without fundoplication in people with Paraesophageal Hernia, run by The Foundation for Surgical Innovation and Education at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with GERD post-op (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05807763, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.

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