Paraesophageal hernia causes pain, heartburn, regurgitation, anemia and in extreme, life-threatening strangulation. For symptomatic patients, laparoscopic surgery is offered which includes hiatal defect closure and antireflux surgery. However, recurrence rates are high between 12 and 42%. In order to reduce recurrences, mesh has been used with various materials and techniques with conflicting results. Non-absorbable mesh has been linked with adverse events including erosion of esophageal wall. Traditionally used biological mesh materials are expensive and therefore problematic in routine use. Use of polyglactin (Vicryl®) mesh, which degrades in 6-8 week, has been reported in paraesophageal hernia surgery. Previously, no randomized controlled trial comparing sutures only and polyglactin mesh has been performed. In this trial, the aim was to randomize total of 110 patients to receive sutures only or mesh repair. Primary outcome was recurrence of paraesophageal hernia at 6 months after the repair based on computed tomography scan. Secondary outcomes included symptomatic recurrences, reoperation rate, quality of life, reoperations up to 20-years after surgery and use of proton pump inhibitors up to 20-years after surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
110
Polyglactin mesh is used in keyhole manner to enforce hiatal closure
Traditional hiatal closure with non-absorbable sutures.
Oulu University Hospital
Oulu, Finland
RECRUITINGRadiographic recurrence of PEH
Computed tomography based recurrence after sutures only versus polyglactin mesh
Time frame: 6 months after surgery
Symptomatic versus asymptomatic recurrence rates
Symptomatic versus asymptomatic recurrence rates based on symptoms and radiographic finding
Time frame: 6 months
Reoperation rate
Reoperation rate related to hiatal hernia recurrence
Time frame: 20 years
Health related quality of life based on score in esophago-gastric questionnaire (EORTC qlq-og25)
The impact of PEH repair method to health-related quality of life score in esophago-gastric questionnaire (EORTC qlq-og25) at 6 months compared to preoperative level. Score is given between 25 and 100 points with higher score meaning worse quality of life.
Time frame: 6 months
Hiatal defect size related to recurrence rate
The correlation with size of hiatal defect (cm\^2) to recurrence rate (scatter plot with defect size in x-axis and recurrent hernias in y-axis)
Time frame: 6 months
BMI and the risk of recurrence
The correlation of BMI to recurrence rate (scatter plot with BMI in x-axis and recurrent hernias in y-axis)
Time frame: 6 months
Proton pump inhibitor (PPI) use
Use on proton pump inhibitors at 1- 3-, 5-, 10- and 20-years after surgery related to intervention method (sutures only or polyglactin mesh)
Time frame: 20 years
Age and the risk of recurrence
The correlation of age (years) to recurrence rate (scatter plot with age in x-axis and recurrent hernias in y-axis)
Time frame: 6 months
Albumin level and the risk of recurrence
The correlation of nutritional status (albumin level) to recurrence rate (scatter plot with albumin in x-axis and recurrent hernias in y-axis)
Time frame: 6 months
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