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Sutures Versus Polyglactin Mesh in Hiatal Hernia Repair

Recruiting
18 years of age
Both
Phase N/A

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Overview

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

Inclusion Criteria:

  • Over 18 years old
  • Type III-IV PEH with either radiologic or endoscopic confirmation
  • Scheduled for laparoscopic PEH repair
  • The informed consent is acquired

Exclusion Criteria:

  • Need for esophagus lengthening procedure (Collis gastroplasty)
  • Recurrent PEH
  • Emergency surgery
  • No written consent

Study details

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

NCT05201508

Oulu University Hospital

25 January 2024

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