Gastroesophageal Reflux, GERD, Hiatal Hernia With Gastroesophageal Reflux Disease
Conditions
Brief summary
Investigator will identify a consecutive cohort of patients who have undergone a hiatal hernia repair and are at least 6 months post index procedure.
Detailed description
Planned Sample Size: At minimum of 70 consecutive subjects at least 6-months post-index procedure Study Population: A consecutive cohort of patients who have undergone a hiatal hernia repair with MIROMESH. Primary Objective: Characterize the procedural and early post-operative safety profile of MIROMESH when used as reinforcement in hiatal hernia repair. Secondary Objectives A retrospective chart review will identify the appropriate cohort with a prospective follow-up survey to acquire safety and outcome information. A retrospective chart review of appropriate subjects. Data to be acquired will be: Preoperative - Chart Review * Gender * Date of birth * Weight * Body Mass Index * Specific diagnosis * DeMeester Score * 24 hour pH test (% acid exposure in 24 hours) * Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) Score Peri-operative Preoperative - Chart Review * Date of surgery * Number of stitches used to close wound * Paraesophageal hernia type * Mesh shape * Mesh size used * Attachment technique * Length of stay * Complications Post-Operative (With-in 1 month of surgery) Preoperative - Chart Review * Complications (Mesh related) * Complications (procedure related) * Prolonged dysphagia (Y/N) * Stenosis (Y/N) * Dilations (Y/N) * Esophagogastroduodenoscopy or Upper gastrointestinal series documented hernia recurrence * GERD-HRQL Score Prospective institutional review board approved Follow-Up Telephone Interview * Have you had a revision surgery? * GERD-HRQL Score * How satisfied are you with the procedure? * Have you used proton pump inhibitors in the last 3 months * How likely are you to recommend this procedure to a loved one?
Interventions
BIOLOGICALHepatic derived surgical matrix
Hiatal hernia repair with MIROMESH
Sponsors
Miromatrix Medical Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Had a hiatal hernia repair with MIROMESH greater than 6 months prior to study
Exclusion criteria
* N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Who Required a Revision of the Index Surgery. | 6-18 months post index procedure | Patient self-report if they had a revision or other laparoscopic surgery following index procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastroesophageal Reflux Disease Health Related Quality of Life Score (GERD-HRQL) | 6-18 months post index procedure | The GERD-HRQL score assess the severity of GERD symptomatic and impact on the subjects quality of life. The score is comprised of 10 questions whose answers are summed for the final score. THe score can range from 0 to 50, with 50 being the worst and 0 meaning no impact. |
| Medication Use | 6-18 months post index procedure | Use of PPIs in 3-months prior to follow-up interview |
Other
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction With Procedure | 6-18 Months post index procedure | Patients reported their satisfaction with the procedure as Dissatisfied, Neutral, or Satisfied. |
| Likelihood to Recommend | 6-18 Months post index procedure | Patients were asked to report how likely they would be to recommend this procedure to a friend or loved one with the same condition. Report was based on a scale of 1 (not at all likely) to 10 (very likely). |
Countries
United States
Participant flow
Recruitment details
A consecutive cohort of patients who underwent a hiatal hernia repair between 1 Nov 2015 and 1 Mar 2017 at the principle investigator's private practice were identified. Patients were contacted by phone and asked if they were willing to participate. If so they were consented and enrolled.
Pre-assignment details
12 patients declined participation or could not be contacted. These were included in the baseline analysis.
Participants by arm
| Arm | Count |
|---|---|
| Observations Group Patients who have undergone a hiatal hernia repair with MIROMESH.
Hepatic derived surgical matrix: Hiatal hernia repair with MIROMESH | 85 |
| Total | 85 |
Baseline characteristics
| Characteristic | Observations Group | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 22 Participants | — |
| Age, Categorical Between 18 and 65 years | 63 Participants | — |
| Age, Continuous | 55.9 Years STANDARD_DEVIATION 12.7 | — |
| GERD-HRQL | 27.7 Score STANDARD_DEVIATION 9.3 | — |
| Proton Pump Inhibitor Use No | 12 Participants | — |
| Proton Pump Inhibitor Use Yes | 73 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 85 Participants | — |
| Sex: Female, Male Female | 55 Participants | — |
| Sex: Female, Male Male | 30 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 73 |
| other Total, other adverse events | 3 / 73 |
| serious Total, serious adverse events | 0 / 73 |
Outcome results
Primary
Number of Subjects Who Required a Revision of the Index Surgery.
Patient self-report if they had a revision or other laparoscopic surgery following index procedure.
Time frame: 6-18 months post index procedure
Population: 12 patients declined participation or could not be contacted.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observations Group | Number of Subjects Who Required a Revision of the Index Surgery. | 0 Participants |
Secondary
Gastroesophageal Reflux Disease Health Related Quality of Life Score (GERD-HRQL)
The GERD-HRQL score assess the severity of GERD symptomatic and impact on the subjects quality of life. The score is comprised of 10 questions whose answers are summed for the final score. THe score can range from 0 to 50, with 50 being the worst and 0 meaning no impact.
Time frame: 6-18 months post index procedure
Population: 12 patients declined participation or could not be contacted.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Observations Group | Gastroesophageal Reflux Disease Health Related Quality of Life Score (GERD-HRQL) | 7.1 Score | Standard Deviation 8.1 |
Comparison: Difference between baseline and follow-upp-value: <0.001t-test, 1 sided
Secondary
Medication Use
Use of PPIs in 3-months prior to follow-up interview
Time frame: 6-18 months post index procedure
Population: 12 patients declined participation or could not be contacted. One patient did not answer.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Observations Group | Medication Use | Yes | 7 Participants |
| Observations Group | Medication Use | No | 65 Participants |
Comparison: Difference between baseline and follow-upp-value: <0.0001McNemar
Other Pre-specified
Likelihood to Recommend
Patients were asked to report how likely they would be to recommend this procedure to a friend or loved one with the same condition. Report was based on a scale of 1 (not at all likely) to 10 (very likely).
Time frame: 6-18 Months post index procedure
Population: 12 patients declined participation or could not be contacted.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Observations Group | Likelihood to Recommend | <=3 | 3 Participants |
| Observations Group | Likelihood to Recommend | >= 4 - <= 7 | 6 Participants |
| Observations Group | Likelihood to Recommend | >=8 | 64 Participants |
Other Pre-specified
Satisfaction With Procedure
Patients reported their satisfaction with the procedure as Dissatisfied, Neutral, or Satisfied.
Time frame: 6-18 Months post index procedure
Population: 12 patients declined participation or could not be contacted.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Observations Group | Satisfaction With Procedure | Satisfied | 63 Participants |
| Observations Group | Satisfaction With Procedure | Neutral | 6 Participants |
| Observations Group | Satisfaction With Procedure | Dissatisfied | 4 Participants |