About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Over 18 years old
Type III-IV PEH with either radiologic or endoscopic confirmation
Scheduled for laparoscopic PEH repair
The informed consent is acquired
Disqualifiers
Need for esophagus lengthening procedure (Collis gastroplasty)
Recurrent PEH
Emergency surgery
No written consent
Trial design
Parallel
Treatments tested in this trial
Polyglactin mesh
Procedure/SurgeryPolyglactin mesh is used in keyhole manner to enforce hiatal closure
Sutures only
Procedure/SurgeryTraditional hiatal closure with non-absorbable sutures.
Treatment groups
Trial outcomes
Primary outcomes
Radiographic recurrence of PEH
Computed tomography based recurrence after sutures only versus polyglactin mesh
Secondary outcomes
Symptomatic versus asymptomatic recurrence rates
Symptomatic versus asymptomatic recurrence rates based on symptoms and radiographic finding
Reoperation rate
Reoperation rate related to hiatal hernia recurrence
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.
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)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Oulu University Hospital
Lead sponsor
Central Finland Hospital District
Collaborator