NCT05201508 Sutures Versus Polyglactin Mesh in Hiatal Hernia Repair
| NCT ID | NCT05201508 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oulu University Hospital |
| Condition | Paraesophageal Hernia |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2022-01-21 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2022-01-21 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05201508 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Paraesophageal Hernia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05201508 currently recruiting?
Yes, NCT05201508 is actively recruiting participants. Contact the research team at olli.helminen@oulu.fi for enrollment information.
Where is the NCT05201508 trial being conducted?
This trial is being conducted at Oulu, Finland.
Who is sponsoring the NCT05201508 clinical trial?
NCT05201508 is sponsored by Oulu University Hospital. The trial plans to enroll 110 participants.