Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05807763
Other study ID # STUDY2022000698
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  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