Hiatal Hernia Clinical Trial
Official title:
Hiatal Hernia Repair Using Surgimend Mesh: A Pilot Study
Verified date | March 2023 |
Source | Kettering Health Network |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 9 |
Est. completion date | September 5, 2023 |
Est. primary completion date | August 16, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Kettering Health Network - Grandview Medical Center | Dayton | Ohio |
Lead Sponsor | Collaborator |
---|---|
Kettering Health Network | Integra LifeSciences Corporation |
United States,
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. — View Citation
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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
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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. — View 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. — View 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
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrence Rate | Recurrence rate will be analyzed by a Upper gastrointestinal tract radiography (UGI) and clinical evaluation in conjunction with patient's reported physiological assessment per the GERD-HRQL. | 6 months post surgery | |
Secondary | Quality of Life Using GERD-HRQL Scale | The GERD-HRQL was initially developed to measure the typical symptoms of GERD and their effect on a patient's quality of life. It was initially determined to have face validity and subsequent studies assessed its content validity and criterion validity. Reliability was determined by the test-retest method. This instrument is practical, with little administrative burden and has been validated for use via the telephone call. Scale is 0-5 with 0 being no symptoms and 5 being symptoms are incapacitating. | pre-operative and 3 month and 6 month post surgery |
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