Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05201508

Sutures Versus Polyglactin Mesh in Hiatal Hernia Repair

Led by Oulu University Hospital · Updated on 2023-03-27

110

Participants Needed

1

Research Sites

1092 weeks

Total Duration

On this page

Sponsors

O

Oulu University Hospital

Lead Sponsor

C

Central Finland Hospital District

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Sutures Versus Polyglactin Mesh in Hiatal Hernia Repair

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Over 18 years old
  • Confirmed type III or IV paraesophageal hernia by radiology or endoscopy
  • Scheduled for laparoscopic paraesophageal hernia repair
  • Informed consent obtained
Not Eligible

You will not qualify if you...

  • Need for esophagus lengthening procedure (Collis gastroplasty)
  • Recurrent paraesophageal hernia
  • Emergency surgery required
  • No written consent provided

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Oulu University Hospital

Oulu, Finland, 90220

Actively Recruiting

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Research Team

O

Olli Helminen, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Sutures Versus Polyglactin Mesh in Hiatal Hernia Repair | DecenTrialz