Clinical trial NCT06444347: Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair
Official title: The Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair in Robotic Anti-Reflux Surgery: A Multi-Institutional Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hiatal Hernia
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Intuitive Surgical
First posted: 2024-06-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to find out if using a certain kind of mesh can reduce the chances of hiatal hernias coming back after anti-reflux surgery. Participants undergoing antireflux surgery will be assigned to one of two groups, a group that has surgery with mesh, or a group that has surgery without mesh.


Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of gastroesophageal reflux disease
* Adults aged 18 years or older
* English speaking
* Subject is planned to undergo surgery for reflux disease

Exclusion Criteria:

* Physician deems the subject is unable to complete the study due to documented dementia.
* Subject is undergoing emergent surgery.
* Pregnancy
* Patient has known allergy to tetracycline hydrochloride or kanamycin sulfate

Primary outcomes:
measure: Anatomic hiatal hernia recurrence rate
timeFrame: 1 year
Secondary outcomes:
measure: Anatomic Hiatal Hernia Recurrence rate
timeFrame: 3 years
measure: Anatomic Hiatal Hernia Recurrence rate
timeFrame: 5 years
measure: Reflux Symptoms
timeFrame: 2 weeks postoperatively
measure: Reflux Symptoms
timeFrame: 6 months postoperatively
measure: Reflux Symptoms
timeFrame: 1 year postoperatively
measure: Reflux Symptoms
timeFrame: 2 years postoperatively
measure: Reflux Symptoms
timeFrame: 3 years postoperatively
measure: Reflux Symptoms
timeFrame: 4 years postoperatively
measure: Reflux Symptoms
timeFrame: 5 years postoperatively
measure: Dysphagia Symptoms
timeFrame: 2 weeks postoperatively
measure: Dysphagia Symptoms
timeFrame: 6 months postoperatively
measure: Dysphagia Symptoms
timeFrame: 1 year postoperatively
measure: Dysphagia Symptoms
timeFrame: 2 years postoperatively
measure: Dysphagia Symptoms
timeFrame: 3 years postoperatively
measure: Dysphagia Symptoms
timeFrame: 4 years postoperatively
measure: Dysphagia Symptoms
timeFrame: 5 years postoperatively
measure: Number of subjects requiring 30 day readmission
timeFrame: 30 days following surgery
measure: Number of subjects requiring reoperation
timeFrame: 30 days following surgery
measure: Number of subjects developing postoperative Infection
timeFrame: 30 days following surgery
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California Keck School of Medicine
state: California
city: New Orleans
country: United States
facility: Louisiana State University School of Medicine
state: Louisiana
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Rasa Zarnegar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yamasaki T, Hemond C, Eisa M, Ganocy S, Fass R. The Changing Epidemiology of Gastroesophageal Reflux Disease: Are Patients Getting Younger? J Neurogastroenterol Motil. 2018 Oct 1;24(4):559-569. doi: 10.5056/jnm18140.
citation: Li Q, Blume SW, Huang JC, Hammer M, Ganz ML. Prevalence and healthcare costs of obesity-related comorbidities: evidence from an electronic medical records system in the United States. J Med Econ. 2015;18(12):1020-8. doi: 10.3111/13696998.2015.1067623. Epub 2015 Sep 4.
citation: Oelschlager BK, Pellegrini CA, Hunter JG, Brunt ML, Soper NJ, Sheppard BC, Polissar NL, Neradilek MB, Mitsumori LM, Rohrmann CA, Swanstrom LL. Biologic prosthesis to prevent recurrence after laparoscopic paraesophageal hernia repair: long-term follow-up from a multicenter, prospective, randomized trial. J Am Coll Surg. 2011 Oct;213(4):461-8. doi: 10.1016/j.jamcollsurg.2011.05.017. Epub 2011 Jun 29.
citation: Spiro C, Quarmby N, Gananadha S. Mesh-related complications in paraoesophageal repair: a systematic review. Surg Endosc. 2020 Oct;34(10):4257-4280. doi: 10.1007/s00464-020-07723-0. Epub 2020 Jun 18.
citation: Deeken CR, Matthews BD. Characterization of the Mechanical Strength, Resorption Properties, and Histologic Characteristics of a Fully Absorbable Material (Poly-4-hydroxybutyrate-PHASIX Mesh) in a Porcine Model of Hernia Repair. ISRN Surg. 2013 May 28;2013:238067. doi: 10.1155/2013/238067. Print 2013.
citation: Alicuben ET, Worrell SG, DeMeester SR. Resorbable biosynthetic mesh for crural reinforcement during hiatal hernia repair. Am Surg. 2014 Oct;80(10):1030-3.
citation: Aiolfi A, Cavalli M, Sozzi A, Lombardo F, Lanzaro A, Panizzo V, Bonitta G, Mendogni P, Bruni PG, Campanelli G, Bona D. Medium-term safety and efficacy profile of paraesophageal hernia repair with Phasix-ST(R) mesh: a single-institution experience. Hernia. 2022 Feb;26(1):279-286. doi: 10.1007/s10029-021-02528-z. Epub 2021 Oct 30.
citation: Tartaglia E, Cuccurullo D, Guerriero L, Reggio S, Sagnelli C, Mugione P, Corcione F. The use of biosynthetic mesh in giant hiatal hernia repair: is there a rationale? A 3-year single-center experience. Hernia. 2021 Oct;25(5):1355-1361. doi: 10.1007/s10029-020-02273-9. Epub 2020 Jul 25.
citation: Panici Tonucci T, Asti E, Sironi A, Ferrari D, Bonavina L. Safety and Efficacy of Crura Augmentation with Phasix ST Mesh for Large Hiatal Hernia: 3-Year Single-Center Experience. J Laparoendosc Adv Surg Tech A. 2020 Apr;30(4):369-372. doi: 10.1089/lap.2019.0726. Epub 2020 Jan 7.
citation: Quake, S. Y. L., Peter, B., Munipalle, P. C., & Viswanath, Y. (2023). OGBN O08 The Safety and Efficacy of Laparoscopic Hiatus Hernia Repair with Biosynthetic Mesh (Phasix-ST®): A Single Centre Experience. British Journal of Surgery, 110(Supplement_8), znad348-030.
citation: Konstantinidis H, Charisis C. Surgical treatment of large and complicated hiatal hernias with the new resorbable mesh with hydrogel barrier (Phasix ST): a preliminary study. J Robot Surg. 2023 Feb;17(1):141-146. doi: 10.1007/s11701-022-01406-9. Epub 2022 Apr 9.
citation: Abdelmoaty WF, Dunst CM, Filicori F, Zihni AM, Davila-Bradley D, Reavis KM, Swanstrom LL, DeMeester SR. Combination of Surgical Technique and Bioresorbable Mesh Reinforcement of the Crural Repair Leads to Low Early Hernia Recurrence Rates with Laparoscopic Paraesophageal Hernia Repair. J Gastrointest Surg. 2020 Jul;24(7):1477-1481. doi: 10.1007/s11605-019-04358-y. Epub 2019 Aug 29.