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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
9
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
Kettering Health Network - Grandview Medical Center
Dayton, Ohio, United States
Recurrence Rate
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.
Time frame: 6 months post surgery
Quality of Life Using GERD-HRQL Scale
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.
Time frame: 6 month post surgery
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