Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Comparing sutures and polyglactin mesh for hiatal hernia repair

Official title: Sutures Only Versus Absorbable Polyglactin (Vicryl®) Mesh in Closure of Hiatal Defect in Laparoscopic Paraesophageal Hernia Repair: Randomized Controlled Trial.

Run by Oulu University Hospital · NCT05201508 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment110 (estimated)
SponsorOulu University Hospital
Academic / other
Locations1 site (Oulu)
StatusRecruiting
StartedJanuary 21, 2022
Main results expectedDecember 31, 2024
Study endsJanuary 1, 2043
Registry record updatedMarch 27, 2023
Trial IDNCT05201508 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

Patients requiring esophagus lengthening procedures, those with recurrent hernias, or those needing emergency surgery may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: While previous studies have explored various mesh materials, this is the first randomized controlled trial specifically comparing sutures and polyglactin mesh in this context.

Who can join: the full rules

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 it's running

  • Oulu University Hospital
    Oulu, Finland
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.