Sutures Versus Polyglactin Mesh in Hiatal Hernia Repair
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Polyglactin mesh, Sutures only.
- Who it may be relevant to
- Registry conditions: Paraesophageal Hernia, Hiatal Hernia, Hiatal Hernia, Paraesophageal, Recurrence. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Sutures Only Versus Absorbable Polyglactin (Vicryl®) Mesh in Closure of Hiatal Defect in Laparoscopic Paraesophageal Hernia Repair: Randomized Controlled Trial.
Overview
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.
Interventions
- Procedure Polyglactin mesh
Polyglactin mesh is used in keyhole manner to enforce hiatal closure - Procedure Sutures only
Traditional hiatal closure with non-absorbable sutures.
Primary outcome measures
- Radiographic recurrence of PEH [Time frame: 6 months after surgery]
Secondary outcome measures (8)
- Symptomatic versus asymptomatic recurrence rates [Time frame: 6 months]
- Reoperation rate [Time frame: 20 years]
- Health related quality of life based on score in esophago-gastric questionnaire (EORTC qlq-og25) [Time frame: 6 months]
- Hiatal defect size related to recurrence rate [Time frame: 6 months]
- BMI and the risk of recurrence [Time frame: 6 months]
- Proton pump inhibitor (PPI) use [Time frame: 20 years]
- Age and the risk of recurrence [Time frame: 6 months]
- Albumin level and the risk of recurrence [Time frame: 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Finland · 1 center
- Oulu University Hospital — Oulu
Identifiers
NCT: NCT05201508 · Sutures or mesh for PEH