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
Qualifiers
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
Treatments tested in this trial
- Polyglactin mesh
- Sutures only
Treatment groups
Sponsors and collaborators
Oulu University Hospital
Lead sponsor
Central Finland Hospital District
Collaborator