ACELL Mesh for Paraesophageal Hernia Repair

Status Completed

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03058731
Study type	Observational
Source	University of South Florida
Contact
Status	Completed
Phase
Start date	February 2, 2016
Completion date	January 28, 2019

View Details

See also
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Active, not recruiting	`NCT04179578` - The Value of Lateral Release in Reconstruction of the Diaphragmatic Hiatus Hernia	N/A
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Recruiting	`NCT06193551` - Ovitex in Paraesophageal and Large Hiatal Hernia Repair	N/A
Completed	`NCT01099033` - The Biologic Basis of Hernia Formation

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.