Fundoplication in Laparoscopic PEH Repair Based on FLIP

Paraesophageal Hernia Clinical Trial

— PEHFLIP  

Official title:

Selective Use of Fundoplication in Laparoscopic Paraesophageal Hernia Repair Based on Intra-operative Impedance Planimetry (FLIP)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05807763
• Other study ID #: STUDY2022000698
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 22, 2023
• Est. completion date: February 22, 2029

Study information

• Verified date: March 2023
• Source: The Foundation for Surgical Innovation and Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 260
• Est. completion date: February 22, 2029
• Est. primary completion date: February 22, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Hiatal
• 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".

Locations

Country	Name	City	State
United States	NorthShore University HealthSystem	Evanston	Illinois
United States	Providence Portland Medical Center / The Oregon Clinic	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
The Foundation for Surgical Innovation and Education

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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. — View 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.

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	hernia recurrence	Routine upper GI contrast study and endoscopy will evaluate for hernia recurrence	12 months