SurgiMend Mesh at the Hiatus

Hiatal Hernia Clinical Trial

Official title:

Hiatal Hernia Repair Using Surgimend Mesh: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04282720
• Other study ID #: SurgiMend
• Status: Completed
• Phase: N/A
• Start date: March 31, 2020
• Est. completion date: September 5, 2023

Study information

• Verified date: March 2023
• Source: Kettering Health Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Hernia
• Hernia, Hiatal
• Hiatal Hernia

Intervention

Device:
• SurgiMend Mesh
Following placement of SurgiMend mesh during laparoscopic hiatal hernia repair, patient will be scheduled for follow up using an upper GI series to check for recurrence of the hiatal hernia. Follow up upper GIs will be performed at 6 months post-surgery. Subjects will also complete a QOL survey to assess other GI associated symptoms before and after surgical repair. The QOL survey can be administered by phone by study team members

Locations

Country	Name	City	State
United States	Kettering Health Network - Grandview Medical Center	Dayton	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Kettering Health Network	Integra LifeSciences Corporation

Country where clinical trial is conducted

United States, 

References & Publications (8)

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

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. — View 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

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. — View 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. — 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

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. — View Citation

Outcome

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