Sutures Versus Polyglactin Mesh in Hiatal Hernia Repair

  • STATUS
    Recruiting
  • End date
    Jan 1, 2043
  • participants needed
    110
  • sponsor
    Oulu University Hospital
Updated on 22 March 2022

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.

Details
Condition Paraesophageal Hernia, Hiatal Hernia, Hiatal Hernia, Paraesophageal, Recurrence
Treatment Sutures Only, Polyglactin mesh
Clinical Study IdentifierNCT05201508
SponsorOulu University Hospital
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

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
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