NCT05807763

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
34mo left

Started Feb 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Feb 2023Feb 2029

Study Start

First participant enrolled

February 22, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 29, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 11, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2025

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2029

Expected
Last Updated

November 27, 2024

Status Verified

April 1, 2024

Enrollment Period

2 years

First QC Date

March 29, 2023

Last Update Submit

November 25, 2024

Conditions

Paraesophageal Hernia

Keywords

Paraesophageal hernia repairLaparoscopic paraesophageal hernia repairPEH repairLap PEH repairFLIPFunctional luminal imaging probeGERDGastroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (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.

    12 months

Secondary Outcomes (1)

  • Number of participants with hernia recurrence

    12 months

Study Arms (2)

Control Group

NO INTERVENTION

Fundoplication

Study Group

EXPERIMENTAL

No Fundoplication

Procedure: Laparoscopic paraesophageal hernia repair without fundoplication

Interventions

Laparoscopic paraesophageal hernia repair without fundoplicationPROCEDURE

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 Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing laparoscopic paraesophageal hernia repair

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Providence Portland Medical Center / The Oregon Clinic

Portland, Oregon, 97213, United States

Location

Related Publications (8)

  • 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.

    PMID: 25868406BACKGROUND

  • 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.

    PMID: 32556758BACKGROUND

  • 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.

    PMID: 35972160BACKGROUND

  • 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.

    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.

    PMID: 22955896BACKGROUND

  • 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.

    PMID: 35505258BACKGROUND

  • 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.

    PMID: 35169878BACKGROUND

  • 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.

    PMID: 35838832BACKGROUND

MeSH Terms

Conditions

Hernia, HiatalGastroesophageal Reflux

Interventions

Fundoplication

Condition Hierarchy (Ancestors)

Hernia, DiaphragmaticInternal HerniaHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Christy M Dunst, MD

    The Oregon Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Program Director Complex GI-Foregut Fellowship, Providence Portland Medical Center

Study Record Dates

First Submitted

March 29, 2023

First Posted

April 11, 2023

Study Start

February 22, 2023

Primary Completion

February 22, 2025

Study Completion (Estimated)

February 22, 2029

Last Updated

November 27, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)