Fundoplication in Laparoscopic PEH Repair Based on FLIP (PEHFLIP)

• ClinicalTrials.gov Identifier: NCT05807763
• Recruitment Status: Enrolling by invitation
• First Posted: April 11, 2023
• Last Update Posted: April 11, 2023
• Sponsor: The Foundation for Surgical Innovation and Education
• Information provided by (Responsible Party): Christy M. Dunst, The Oregon Clinic

Tracking Information

• First Submitted Date: March 29, 2023
• First Posted Date: April 11, 2023
• Last Update Posted Date: April 11, 2023
• Actual Study Start Date: February 22, 2023
• Estimated Primary Completion Date: February 22, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 29, 2023)

GERD [ Time Frame: 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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: March 29, 2023)

hernia recurrence [ Time Frame: 12 months ]

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Fundoplication in Laparoscopic PEH Repair Based on FLIP
• Official Title: Selective Use of Fundoplication in Laparoscopic Paraesophageal Hernia Repair Based on Intra-operative Impedance Planimetry (FLIP)
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Paraesophageal Hernia

Intervention

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".

Study Arms

• No Intervention: Control Group
  Fundoplication
• Experimental: Study Group
  No Fundoplication
  Intervention: Procedure: Laparoscopic paraesophageal hernia repair without fundoplication

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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: March 29, 2023): 260
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 22, 2029
• Estimated Primary Completion Date: February 22, 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05807763
• Other Study ID Numbers: STUDY2022000698
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Christy M. Dunst, The Oregon Clinic
• Original Responsible Party: Same as current
• Current Study Sponsor: The Foundation for Surgical Innovation and Education
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Christy M Dunst, MD; The Oregon Clinic

• PRS Account: The Foundation for Surgical Innovation and Education
• Verification Date: March 2023