Hiatal Hernia
Conditions
Brief 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.
Interventions
DEVICESurgiMend 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
Sponsors
Kettering Health Network
Integra LifeSciences Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence Rate | 6 months post surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Using GERD-HRQL Scale | 6 month post surgery | GERD-HRQL was developed to measure the typical symptoms of GERD and the effect on a patient's quality of life. Scale is 0-5 with 0 being no symptoms and 5 being symptoms are incapacitating. Total score is calculated by summing the individual scores to questions 1-15 with greatest possible score (worst symptoms) = 75 and lowest possible score (no symptoms) = 0. The total score is made up of two sub scores which addressed heartburn and regurgitation symptoms and are reported separately in a heartburn score and regurgitation score as well as the total GERD-HRQL score. The follow up scores were combined due to some participants not having specific follow up information. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPaul Levy, DO
Kettering Health Network
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 64.7 years |
| GERD-HRQL survey | 35.44 0-75 score on survey STANDARD_DEVIATION 18.035 |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
None listed