Comparing sutures and polyglactin mesh for hiatal hernia repair
Sutures Only Versus Absorbable Polyglactin (Vicryl®) Mesh in Closure of Hiatal Defect in Laparoscopic Paraesophageal Hernia Repair: Randomized Controlled Trial.
NA · Oulu University Hospital · NCT05201508
This study is testing whether using mesh instead of just stitches during surgery can help prevent paraesophageal hernias from coming back in patients.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oulu University Hospital (other) |
| Locations | 1 site (Oulu) |
| Trial ID | NCT05201508 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of sutures only versus polyglactin mesh in repairing paraesophageal hernias. It involves randomizing 110 patients who are scheduled for laparoscopic surgery to either receive sutures or the mesh during their procedure. The primary outcome being measured is the recurrence of the hernia within six months post-surgery. The study seeks to address high recurrence rates associated with traditional repair methods and explore a potentially safer and more cost-effective alternative.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with type III-IV paraesophageal hernias confirmed by imaging or endoscopy, who are scheduled for laparoscopic repair.
Not a fit: Patients requiring esophagus lengthening procedures, those with recurrent hernias, or those needing emergency surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced recurrence rates for patients undergoing hiatal hernia repair.
How similar studies have performed: While previous studies have explored various mesh materials, this is the first randomized controlled trial specifically comparing sutures and polyglactin mesh in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Oulu
- Oulu University Hospital — Oulu, Finland (RECRUITING)
Study contacts
- Study coordinator: Olli Helminen, MD, PhD
- Email: olli.helminen@oulu.fi
- Phone: +35883152011
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Paraesophageal Hernia, Hiatal Hernia, Hiatal Hernia, Paraesophageal, Recurrence