Oulu University Hospital
Oulu, 90220, Finland
Location status: Recruiting
NCT Number: NCT05201508
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Oulu, 90220, Finland
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Polyglactin mesh is used in keyhole manner to enforce hiatal closure
Traditional hiatal closure with non-absorbable sutures.
Time frame: 6 months after surgery
Computed tomography based recurrence after sutures only versus polyglactin mesh
Time frame: 6 months
Symptomatic versus asymptomatic recurrence rates based on symptoms and radiographic finding
Time frame: 20 years
Reoperation rate related to hiatal hernia recurrence
Time frame: 6 months
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
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
The correlation of BMI to recurrence rate (scatter plot with BMI in x-axis and recurrent hernias in y-axis)
Time frame: 20 years
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: 6 months
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
The correlation of nutritional status (albumin level) to recurrence rate (scatter plot with albumin in x-axis and recurrent hernias in y-axis)
Contact information is provided by the study sponsor or research team.
Oulu University Hospital
Other
Sutures Only Versus Absorbable Polyglactin (Vicryl®) Mesh in Closure of Hiatal Defect in Laparoscopic Paraesophageal Hernia Repair: Randomized Controlled Trial.
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