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Study identifier: NCT05201508 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Sutures Versus Polyglactin Mesh in Hiatal Hernia Repair

Condition: Paraesophageal Hernia · Hiatal Hernia · Hiatal Hernia, Paraesophageal  ·  Sponsor: Oulu University Hospital

PhaseNA
Planned participants110
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Olli Helminen, MD, PhD  ·  +35883152011  ·  olli.helminen@oulu.fi

Always discuss trial participation with your own doctor first.

Locations (1)

Oulu University HospitalOulu, FinlandRecruiting

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Source record: clinicaltrials.gov/study/NCT05201508