SurgiMend Mesh at the Hiatus

Not Applicable

Completed

• Conditions: Hiatal Hernia
• Interventions: Device: SurgiMend Mesh

• Registration Number: NCT04282720
• Lead Sponsor: Kettering Health Network

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-21
• Study First Submitted QC: 2020-02-21
• Study First Posted: 2020-02-25
• Study Start: 2020-03-31
• Status Verified: 2023-03
• Primary Completion: 2023-08-16
• Study Completion: 2023-09-05
• Last Update Submitted: 2023-10-04
• Last Update Posted: 2023-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SurgiMend Mesh	SurgiMend Mesh	SurgiMend Mesh - FDA approved noncross-linked bovine dermis biologic mesh. SurgiMend Mesh will be used according to FDA approved recommendations for the use of abdominal wall hernia reinforcement. SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. SurgiMend is specifically indicated for: Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Quality of Life Using GERD-HRQL Scale	pre-operative and 3 month and 6 month post surgery	The GERD-HRQL was initially developed to measure the typical symptoms of GERD and their effect on a patient's quality of life. It was initially determined to have face validity and subsequent studies assessed its content validity and criterion validity. Reliability was determined by the test-retest method. This instrument is practical, with little administrative burden and has been validated for use via the telephone call. Scale is 0-5 with 0 being no symptoms and 5 being symptoms are incapacitating.

Trial Locations

Locations (1)

Kettering Health Network - Grandview Medical Center; 🇺🇸 Dayton, Ohio, United States