ACELL Mesh for Paraesophageal Hernia Repair
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/30/2019 |
| Start Date: | February 2, 2016 |
| End Date: | January 28, 2019 |
Comparison of Symptomatic and Radiographic Outcomes of Paraesophageal Hernia Repair With and Without MatriStem Surgical Matrix
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.
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.
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.
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.
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
We found this trial at
1
site
1 Tampa General Cir
Tampa, Florida 33606
Tampa, Florida 33606
(813) 844-7000
Principal Investigator: Vic Velanovich, MD
Phone: 813-844-7948
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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