Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Oulu University Hospital
Oulu, Finland, 90220
Actively Recruiting
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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