ACELL Mesh for Paraesophageal Hernia Repair

Paraesophageal Hernia Clinical Trial

Official title:

Comparison of Symptomatic and Radiographic Outcomes of Paraesophageal Hernia Repair With and Without MatriStem Surgical Matrix

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03058731
• Other study ID #: ACELL01
• Status: Completed
• Start date: February 2, 2016
• Est. completion date: January 28, 2019

Study information

• Verified date: March 2019
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective, case-matched, systematic follow up of up to 70 pre-existing patients whom underwent paraesophageal hernia repair between June 1, 2012 and September 30, 2016. Patients whom are willing to participate in the study will be asked to return for a one time follow up visit to reassess for hiatal hernia recurrence both symptomatically and radiologically to compare the efficacy of the use of MatriStem Surgical Matrix (ACell) mesh to other biologic meshes.

Description:

The participating "MatriStem" patients (N=35) will be matched to "control" patients who were treated surgically by Dr. Vic Velanovich or Dr. Michael Albrink for paraesophageal hernia with a biological mesh other than MatriStem Surgical Matrix (N=35) during the study timeframe at Tampa General Hospital. Patients will be matched by age (+ 5 years), gender, and operative approach (laparoscopic, laparotomy, or thoracic approach).

Study participation will require only one visit. Once the patient signs the consent form, operative details and the postoperative course will be reviewed retrospectively.

Visit 1 (≥ 12 months post-PEHR)

1. Review the study with the subject and/or subject's legal representative, and obtain written informed consent and HIPAA authorization.

2. Assign the subject a unique screening/enrollment number (assigned sequentially starting from 001).

3. Pregnancy test if subject is of childbearing potential

4. Confirm subject eligibility.

5. Record demographics data, which includes date of birth, race, ethnicity, and gender.

6. Record current clinical symptoms in relation to the HH.

7. Record medications, including over-the-counter and herbal medications, taken postoperatively in relation to the HH.

8. Record medical history with respect to the paraesophageal hernia prior to the surgical repair. If available, the following information will be recorded: hernia type, hernia size, organo-axial, or meso-axial rotation, and operative approach (laparoscopic, laparotomy, or thoracic approach).

9. Record medical history with respect to the paraesophageal hernia after the surgical repair (size of mesh implant, length of surgery [calculated as the time from incision to wound closure], postoperative complications to include need for reoperation, mesh migration, reherniation, etc [from date of hospital discharge to study visit], and symptom frequency).

10. Perform esophagogram at TGH.

11. Administer GERD-HRQL symptom severity questionnaire.

12. Administer SF-36 generic quality of life instrument.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: January 28, 2019
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years and older

• Underwent primary or re-do PEHR with biological mesh by Dr. Vic Velanovich or Dr. Michael Albrink between June 1, 2012 and September 30, 2016

• Written informed consent obtained from subject prior to esophagogram procedure and ability for subject to comply with the requirements of the study

Exclusion Criteria:

• Age < 18 years of age

• Underwent PEHR by a surgeon other than Dr. Vic Velanovich or Dr. Michael Albrink

• Underwent PEHR outside of the timeframe of June 1, 2012 and September 30, 2016

• Subject is involved in ongoing medical litigation, confirmed via subject report

• Subject is incarcerated, confirmed via subject report

• Pregnant

Related Conditions & MeSH terms

• Hernia
• Hernia, Hiatal
• Paraesophageal Hernia

Intervention

Device:
• Matristem
Paraesophageal hernia repair with MatriStem Surgical Matrix
• Control
Paraesophageal hernia repair with other biologic mesh

Locations

Country	Name	City	State
United States	Tampa General Hospital	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	ACell Inc.

Country where clinical trial is conducted

United States, 

References & Publications (4)

Hashemi M, Peters JH, DeMeester TR, Huprich JE, Quek M, Hagen JA, Crookes PF, Theisen J, DeMeester SR, Sillin LF, Bremner CG. Laparoscopic repair of large type III hiatal hernia: objective followup reveals high recurrence rate. J Am Coll Surg. 2000 May;19 — View Citation

Mattar SG, Bowers SP, Galloway KD, Hunter JG, Smith CD. Long-term outcome of laparoscopic repair of paraesophageal hernia. Surg Endosc. 2002 May;16(5):745-9. Epub 2002 Feb 8. — View Citation

Oelschlager BK, Pellegrini CA, Hunter J, Soper N, Brunt M, Sheppard B, Jobe B, Polissar N, Mitsumori L, Nelson J, Swanstrom L. Biologic prosthesis reduces recurrence after laparoscopic paraesophageal hernia repair: a multicenter, prospective, randomized trial. Ann Surg. 2006 Oct;244(4):481-90. — View 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. Erratum in: J Am Coll Surg. 2011 Dec;213(6):815. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of hernia recurrence		12 months
Secondary	Mean vertical height of hiatal hernia	For patients with hiatal hernia recurrence	12 months
Secondary	Mean cross-sectional area of hiatal hernia	For patients with hiatal hernia recurrence	12 months
Secondary	Rate of postoperative complications		12 months
Secondary	Mean GERD-Health Related QOL score		12 months
Secondary	Mean SF-36 QOL score		12 months