The aim of this study is to find out if using a certain kind of mesh can reduce the chances of hiatal hernias coming back after anti-reflux surgery. Participants undergoing antireflux surgery will be assigned to one of two groups, a group that has surgery with mesh, or a group that has surgery without mesh.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
The biosynthetic mesh group will undergo hiatal hernia repair with Phasix Mesh (Becton Dickinson, Franklin Lakes, NJ) reinforcement, secured with permanent suture.
The non-mesh group will undergo hiatal hernia repair with permanent suture only.
University of Southern California Keck School of Medicine
Los Angeles, California, United States
WITHDRAWNLouisiana State University School of Medicine
New Orleans, Louisiana, United States
WITHDRAWNWashington University School of Medicine
St Louis, Missouri, United States
Anatomic hiatal hernia recurrence rate
Time frame: 1 year
Anatomic Hiatal Hernia Recurrence rate
Time frame: 3 years
Anatomic Hiatal Hernia Recurrence rate
Time frame: 5 years
Reflux Symptoms
Reflux symptoms will be assessed using the gastroesophageal reflux disease health related quality of life survey (GERD-HRQL). The highest possible score on this survey is 75, indicating daily incapacitating symptoms in all areas assessed. The lowest possible score is 0, indicating no symptoms.
Time frame: 2 weeks postoperatively
Reflux Symptoms
Reflux symptoms will be assessed using the gastroesophageal reflux disease health related quality of life survey (GERD-HRQL). The highest possible score on this survey is 75, indicating daily incapacitating symptoms in all areas assessed. The lowest possible score is 0, indicating no symptoms.
Time frame: 6 months postoperatively
Reflux Symptoms
Reflux symptoms will be assessed using the gastroesophageal reflux disease health related quality of life survey (GERD-HRQL). The highest possible score on this survey is 75, indicating daily incapacitating symptoms in all areas assessed. The lowest possible score is 0, indicating no symptoms.
Time frame: 1 year postoperatively
Reflux Symptoms
Reflux symptoms will be assessed using the gastroesophageal reflux disease health related quality of life survey (GERD-HRQL). The highest possible score on this survey is 75, indicating daily incapacitating symptoms in all areas assessed. The lowest possible score is 0, indicating no symptoms.
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NYU Langone Health
New York, New York, United States
NOT_YET_RECRUITINGWeill Cornell Medicine
New York, New York, United States
RECRUITINGLenox Hill Hospital
New York, New York, United States
NOT_YET_RECRUITINGTime frame: 2 years postoperatively
Reflux Symptoms
Reflux symptoms will be assessed using the gastroesophageal reflux disease health related quality of life survey (GERD-HRQL). The highest possible score on this survey is 75, indicating daily incapacitating symptoms in all areas assessed. The lowest possible score is 0, indicating no symptoms.
Time frame: 3 years postoperatively
Reflux Symptoms
Reflux symptoms will be assessed using the gastroesophageal reflux disease health related quality of life survey (GERD-HRQL). The highest possible score on this survey is 75, indicating daily incapacitating symptoms in all areas assessed. The lowest possible score is 0, indicating no symptoms.
Time frame: 4 years postoperatively
Reflux Symptoms
Reflux symptoms will be assessed using the gastroesophageal reflux disease health related quality of life survey (GERD-HRQL). The highest possible score on this survey is 75, indicating daily incapacitating symptoms in all areas assessed. The lowest possible score is 0, indicating no symptoms.
Time frame: 5 years postoperatively
Dysphagia Symptoms
Dysphagia symptoms will be assessed using the Bazaz dysphagia score. The lowest dysphagia severity score being "none", indicating no difficulty swallowing. The highest dysphagia severity score being "severe", indicating frequent difficulty swallowing with the majority of foods.
Time frame: 2 weeks postoperatively
Dysphagia Symptoms
Dysphagia symptoms will be assessed using the Bazaz dysphagia score. The lowest dysphagia severity score being "none", indicating no difficulty swallowing. The highest dysphagia severity score being "severe", indicating frequent difficulty swallowing with the majority of foods.
Time frame: 6 months postoperatively
Dysphagia Symptoms
Dysphagia symptoms will be assessed using the Bazaz dysphagia score. The lowest dysphagia severity score being "none", indicating no difficulty swallowing. The highest dysphagia severity score being "severe", indicating frequent difficulty swallowing with the majority of foods.
Time frame: 1 year postoperatively
Dysphagia Symptoms
Dysphagia symptoms will be assessed using the Bazaz dysphagia score. The lowest dysphagia severity score being "none", indicating no difficulty swallowing. The highest dysphagia severity score being "severe", indicating frequent difficulty swallowing with the majority of foods.
Time frame: 2 years postoperatively
Dysphagia Symptoms
Dysphagia symptoms will be assessed using the Bazaz dysphagia score. The lowest dysphagia severity score being "none", indicating no difficulty swallowing. The highest dysphagia severity score being "severe", indicating frequent difficulty swallowing with the majority of foods.
Time frame: 3 years postoperatively
Dysphagia Symptoms
Dysphagia symptoms will be assessed using the Bazaz dysphagia score. The lowest dysphagia severity score being "none", indicating no difficulty swallowing. The highest dysphagia severity score being "severe", indicating frequent difficulty swallowing with the majority of foods.
Time frame: 4 years postoperatively
Dysphagia Symptoms
Dysphagia symptoms will be assessed using the Bazaz dysphagia score. The lowest dysphagia severity score being "none", indicating no difficulty swallowing. The highest dysphagia severity score being "severe", indicating frequent difficulty swallowing with the majority of foods.
Time frame: 5 years postoperatively
Number of subjects requiring 30 day readmission
Time frame: 30 days following surgery
Number of subjects requiring reoperation
Time frame: 30 days following surgery
Number of subjects developing postoperative Infection
Time frame: 30 days following surgery