Sutures Versus Polyglactin Mesh in Hiatal Hernia Repair

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

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.

Study Overview

• Status: Recruiting
• Conditions: Recurrence; Hiatal Hernia; Hiatal Hernia, Paraesophageal; Paraesophageal Hernia
• Intervention / Treatment: Procedure: Sutures only; Procedure: Polyglactin mesh

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olli Helminen, MD, PhD; Phone Number: +35883152011; Email: olli.helminen@oulu.fi

Study Locations

• Finland
  • Oulu, Finland, 90220
    • Recruiting
    • Oulu University Hospital
    • Contact: Olli Helminen, MD, PhD; Phone Number: +35883152011; Email: olli.helminen@oulu.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Oulu University Hospital
• Collaborators: Central Finland Hospital District

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): January 1, 2043

Study Registration Dates

• First Submitted: December 16, 2021
• First Submitted That Met QC Criteria: January 19, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 24, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Anatomical; Hernia, Diaphragmatic; Internal Hernia; Hernia; Recurrence; Hernia, Hiatal
• Other Study ID Numbers: Sutures or mesh for PEH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No