NCT05201508

Sutures Versus Polyglactin Mesh in Hiatal Hernia Repair

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Oulu University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Polyglactin mesh	Polyglactin mesh is used in keyhole manner to enforce hiatal closure
PROCEDURE	Sutures only	Traditional hiatal closure with non-absorbable sutures.

Timeline

• Start date: 2022-01-21
• Primary completion: 2024-12-31
• Completion: 2043-01-01
• First posted: 2022-01-21
• Last updated: 2023-03-27

Locations

1 site across 1 country: Finland