Sutures Versus Polyglactin Mesh in Hiatal Hernia Repair

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-21

Study Completion Date

2043-01-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Paraesophageal Hernia Hiatal Hernia Hiatal Hernia, Paraesophageal Recurrence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective open label randomized trial

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Sutures only

Traditional suture closure of hiatal defect

Group Type ACTIVE_COMPARATOR

Sutures only

Intervention Type PROCEDURE

Traditional hiatal closure with non-absorbable sutures.

Polyglactin mesh

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

Group Type EXPERIMENTAL

Polyglactin mesh

Intervention Type PROCEDURE

Polyglactin mesh is used in keyhole manner to enforce hiatal closure

Interventions

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Polyglactin mesh

Polyglactin mesh is used in keyhole manner to enforce hiatal closure

Intervention Type PROCEDURE

Sutures only

Traditional hiatal closure with non-absorbable sutures.

Intervention Type PROCEDURE

Eligibility Criteria

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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