Sutures Versus Polyglactin Mesh in Hiatal Hernia Repair

Oulu University Hospital

Status: Enrolling

Conditions: Hiatal Hernia; Hiatal Hernia, Paraesophageal; Paraesophageal Hernia; Recurrence

Treatments: Procedure: Polyglactin mesh; Procedure: Sutures only

Study type: Interventional

Funder types: Other

Identifiers

NCT05201508

Sutures or mesh for PEH

Details and patient eligibility

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Sutures only

Active Comparator group

Description:

Traditional suture closure of hiatal defect

Treatment:

Procedure: Sutures only

Polyglactin mesh

Experimental group

Description:

In addition to traditional sutures, key hole polyglactin mesh for hiatal defect closure.

Treatment:

Procedure: Polyglactin mesh