Assessment of the recurrence of hiatal hernia five to ten years after repair using sutures versus sutures reinforced with non-absorbable mesh.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Augmentation of hiatal hernia repair with TiMESH® reinforcement
Primary laparoscopic repair of the hiatal hernia using non-absorbable sutures
Percentage of objective recurrence of a hiatal hernia
Objective measurement of the integrity of the hiatal hernia repair by CT-imaging
Time frame: 5-10 years
Percentage of clinical recurrence of a hiatal hernia
Recurrence of symptoms related to a hiatal hernia measured by a questionnaire
Time frame: 5-10 years
Symptoms of gastroesophageal reflux disease
Percentage of participants that develop postoperative gastroesophageal reflux disease, measured by a questionnaire
Time frame: 5-10 years
Patient satisfaction
Overall satisfaction with surgical outcome measured by a questionnaire, on a scale from 0 to 10, where 0 means very unsatisfied with the outcome of the operation and 10 means very satisfied with the outcome of the operation. An additional question will be asked that assesses if the patient would undergo the operation again and can be answered by a simple 'yes' or 'no'.
Time frame: 5-10 years
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