Clinical trial NCT04282720: SurgiMend Mesh at the Hiatus
Official title: Hiatal Hernia Repair Using Surgimend Mesh: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiatal Hernia
Lead sponsor: Kettering Health Network
Sponsor class: OTHER
Collaborators: name: Integra LifeSciences Corporation
First posted: 2020-02-25
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Prospective, single-arm, open-label study to evaluate re-occurrence and quality of life in subjects undergoing primary Hiatal hernia repair using SurgiMend biological mesh. Up to 15, with a target of 10, subjects are planned to be enrolled at one site. All subjects will receive the SurgiMend mesh during surgery. Data collected will be compared to historical data.

Subjects will complete a pre-operative visit. After surgery, in addition to any standard of care visits, subjects will complete 3- and 6-month follow-ups involving a phone QOL survey and will have an upper GI series at 6 months.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of type 3 or 4 hiatal hernia (8)
* Subject is able to give informed consent
* Adults at least 18 years of age

Exclusion Criteria:

* Currently pregnant
* Prior hiatal hernia repair
* Prior gastric surgery
* Prior foregut surgery
* Known esophageal dysfunction or dysmotility
* Cirrhosis or ascites
* Known malignancy
* Known allergy to biologic mesh
* Known allergy to barium or other contrast material used in UGI
* Religious objection to animal implant
* Cognitive impairment
* Prisoners

Primary outcomes:
measure: Recurrence Rate
timeFrame: 6 months post surgery
Secondary outcomes:
measure: Quality of Life Using GERD-HRQL Scale
timeFrame: pre-operative and 3 month and 6 month post surgery
Other outcomes:
Locations:
city: Dayton
country: United States
facility: Kettering Health Network - Grandview Medical Center
state: Ohio
Study officials:
affiliation: Kettering Health Network
name: Paul Levy, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Furnee E, Hazebroek E. Mesh in laparoscopic large hiatal hernia repair: a systematic review of the literature. Surg Endosc. 2013 Nov;27(11):3998-4008. doi: 10.1007/s00464-013-3036-y. Epub 2013 Jun 21.
citation: Lidor AO, Steele KE, Stem M, Fleming RM, Schweitzer MA, Marohn MR. Long-term quality of life and risk factors for recurrence after laparoscopic repair of paraesophageal hernia. JAMA Surg. 2015 May;150(5):424-31. doi: 10.1001/jamasurg.2015.25.
citation: Nason KS, Luketich JD, Qureshi I, Keeley S, Trainor S, Awais O, Shende M, Landreneau RJ, Jobe BA, Pennathur A. Laparoscopic repair of giant paraesophageal hernia results in long-term patient satisfaction and a durable repair. J Gastrointest Surg. 2008 Dec;12(12):2066-75; discussion 2075-7. doi: 10.1007/s11605-008-0712-7. Epub 2008 Oct 8.
citation: Adelman DM, Selber JC, Butler CE. Bovine versus Porcine Acellular Dermal Matrix: A Comparison of Mechanical Properties. Plast Reconstr Surg Glob Open. 2014 Jun 6;2(5):e155. doi: 10.1097/GOX.0000000000000072. eCollection 2014 May.
citation: Velanovich V. The development of the GERD-HRQL symptom severity instrument. Dis Esophagus. 2007;20(2):130-4. doi: 10.1111/j.1442-2050.2007.00658.x.
citation: Radiologic Society of North America (2019). Radiation dose in X-Ray and CT Exam. Available at https://www.radiologyinfo.org/en/info.cfm?pg=safety-xray
citation: K. S. Silvipriya, K. Krishna Kumar*, A. R. Bhat, B. Dinesh Kumar, Anish John, Panayappan Lakshmanan. Collagen: Animal Sources and Biomedical Application. Journal of Applied Pharmaceutical Science Vol. 5 (03), pp. 123-127, March, 2015. DOI: 10.7324/JAPS.2015.50322
citation: Kahrilas PJ, Kim HC, Pandolfino JE. Approaches to the diagnosis and grading of hiatal hernia. Best Pract Res Clin Gastroenterol. 2008;22(4):601-16. doi: 10.1016/j.bpg.2007.12.007.