Sutures Versus Polyglactin Mesh in Hiatal Hernia Repair

Study Overview
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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.

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

Conditions
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Paraesophageal Hernia, Hiatal Hernia, Hiatal Hernia, Paraesophageal, Recurrence

Intervention / Treatment
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* Procedure: Polyglactin mesh
* Procedure: Sutures only


Participation Criteria
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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 Exclusion Criteria: Need for esophagus lengthening procedure (Collis gastroplasty) Recurrent PEH Emergency surgery No written consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective open label randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sutures only<br>Traditional suture closure of hiatal defect | Procedure: Sutures only<br>* Traditional hiatal closure with non-absorbable sutures.<br>|
| Experimental: Polyglactin mesh<br>In addition to traditional sutures, key hole polyglactin mesh for hiatal defect closure. | Procedure: Polyglactin mesh<br>* Polyglactin mesh is used in keyhole manner to enforce hiatal closure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic recurrence of PEH | Computed tomography based recurrence after sutures only versus polyglactin mesh | 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptomatic versus asymptomatic recurrence rates | Symptomatic versus asymptomatic recurrence rates based on symptoms and radiographic finding | 6 months | 
| Reoperation rate | Reoperation rate related to hiatal hernia recurrence | 20 years | 
| Health related quality of life based on score in esophago-gastric questionnaire (EORTC qlq-og25) | The impact of PEH repair method to health-related quality of life score in esophago-gastric questionnaire (EORTC qlq-og25) at 6 months compared to preoperative level. Score is given between 25 and 100 points with higher score meaning worse quality of life. | 6 months | 
| Hiatal defect size related to recurrence rate | The correlation with size of hiatal defect (cm^2) to recurrence rate (scatter plot with defect size in x-axis and recurrent hernias in y-axis) | 6 months | 
| BMI and the risk of recurrence | The correlation of BMI to recurrence rate (scatter plot with BMI in x-axis and recurrent hernias in y-axis) | 6 months | 
| Proton pump inhibitor (PPI) use | Use on proton pump inhibitors at 1- 3-, 5-, 10- and 20-years after surgery related to intervention method (sutures only or polyglactin mesh) | 20 years | 
| Age and the risk of recurrence | The correlation of age (years) to recurrence rate (scatter plot with age in x-axis and recurrent hernias in y-axis) | 6 months | 
| Albumin level and the risk of recurrence | The correlation of nutritional status (albumin level) to recurrence rate (scatter plot with albumin in x-axis and recurrent hernias in y-axis) | 6 months |