SurgiMend Mesh at the Hiatus

Kettering Health Network9 enrolled

Overview

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

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Hiatal Hernia

Interventions

SurgiMend MeshDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Kettering Health Network - Grandview Medical Center

Dayton, Ohio, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.