Sutures Versus Polyglactin Mesh in Hiatal Hernia Repair

Recurrence Clinical Trial

Official title: Sutures Only Versus Absorbable Polyglactin (Vicryl®) Mesh in Closure of Hiatal Defect in Laparoscopic Paraesophageal Hernia Repair: Randomized Controlled Trial.

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Hernia
• Hernia, Hiatal
• Hiatal Hernia
• Hiatal Hernia, Paraesophageal
• Paraesophageal Hernia
• Recurrence

• NCT number: NCT05201508
• Study type: Interventional
• Source: Oulu University Hospital
• Contact: Olli Helminen, MD, PhD
• Phone: +35883152011
• Email: olli.helminen@oulu.fi
• Status: Recruiting
• Phase: N/A
• Start date: January 21, 2022
• Completion date: January 1, 2043