Paraesophageal Hernia Clinical Trial
— PEHFLIPOfficial title:
Selective Use of Fundoplication in Laparoscopic Paraesophageal Hernia Repair Based on Intra-operative Impedance Planimetry (FLIP)
Verified date | March 2023 |
Source | The Foundation for Surgical Innovation and Education |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | NorthShore University HealthSystem | Evanston | Illinois |
United States | Providence Portland Medical Center / The Oregon Clinic | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
The Foundation for Surgical Innovation and Education |
United States,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT00786084 -
Study of Paraesophageal Hernia Repair With Small Intestine Submucosa
|
N/A | |
Recruiting |
NCT05974722 -
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
|
N/A | |
Recruiting |
NCT01799967 -
Minimally Invasive Surgery of the Gastro-esophageal Junction
|
||
Completed |
NCT01776827 -
Long-term Outcome of Laparoscopic Hiatal Hernia Repair With or Without Alloderm Mesh at a University Hospital
|
||
Completed |
NCT04436159 -
Partial Versus Total Fundoplication in the Surgical Repair of Para-esophageal Hernia.
|
N/A | |
Completed |
NCT04007952 -
Anterior Gastropexy vs. No Anterior Gastropexy for Paraesophageal Hernia Repair
|
N/A | |
Not yet recruiting |
NCT06096402 -
Gastropexy as a Treatment Option for Paraesophageal Hernia
|
||
Recruiting |
NCT06107634 -
Gastropexy in the Repair of Patients With Paraesophageal Hernias
|
N/A | |
Completed |
NCT00272922 -
Randomized, Prospective Controlled Trial of Paraesophageal Hernia Repair With Small Intestinal Submucosa (SIS)
|
N/A | |
Active, not recruiting |
NCT04179578 -
The Value of Lateral Release in Reconstruction of the Diaphragmatic Hiatus Hernia
|
N/A | |
Recruiting |
NCT05201508 -
Sutures Versus Polyglactin Mesh in Hiatal Hernia Repair
|
N/A | |
Completed |
NCT01587859 -
Short Esophagus in Type II-IV Hiatus Hernia
|
N/A | |
Completed |
NCT01606449 -
Follow-up of Patients Operated Upon for Type II-IV Hiatal Hernia
|
N/A | |
Completed |
NCT03058731 -
ACELL Mesh for Paraesophageal Hernia Repair
|
||
Recruiting |
NCT06193551 -
Ovitex in Paraesophageal and Large Hiatal Hernia Repair
|
N/A | |
Completed |
NCT01099033 -
The Biologic Basis of Hernia Formation
|