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Sutures Versus Polyglactin Mesh in Hiatal Hernia Repair

Primary Purpose

Paraesophageal Hernia, Hiatal Hernia, Hiatal Hernia, Paraesophageal

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Polyglactin mesh
Sutures only
Sponsored by
Oulu University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Paraesophageal Hernia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Oulu University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Sutures only

Polyglactin mesh

Arm Description

Traditional suture closure of hiatal defect

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

Outcomes

Primary Outcome Measures

Radiographic recurrence of PEH
Computed tomography based recurrence after sutures only versus polyglactin mesh

Secondary Outcome Measures

Symptomatic versus asymptomatic recurrence rates
Symptomatic versus asymptomatic recurrence rates based on symptoms and radiographic finding
Reoperation rate
Reoperation rate related to hiatal hernia recurrence
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.
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)
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)
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)
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)
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)

Full Information

First Posted
December 16, 2021
Last Updated
March 24, 2023
Sponsor
Oulu University Hospital
Collaborators
Central Finland Hospital District
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1. Study Identification

Unique Protocol Identification Number
NCT05201508
Brief Title
Sutures Versus Polyglactin Mesh in Hiatal Hernia Repair
Official Title
Sutures Only Versus Absorbable Polyglactin (Vicryl®) Mesh in Closure of Hiatal Defect in Laparoscopic Paraesophageal Hernia Repair: Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 21, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
January 1, 2043 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oulu University Hospital
Collaborators
Central Finland Hospital District

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paraesophageal Hernia, Hiatal Hernia, Hiatal Hernia, Paraesophageal, Recurrence

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective open label randomized trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sutures only
Arm Type
Active Comparator
Arm Description
Traditional suture closure of hiatal defect
Arm Title
Polyglactin mesh
Arm Type
Experimental
Arm Description
In addition to traditional sutures, key hole polyglactin mesh for hiatal defect closure.
Intervention Type
Procedure
Intervention Name(s)
Polyglactin mesh
Intervention Description
Polyglactin mesh is used in keyhole manner to enforce hiatal closure
Intervention Type
Procedure
Intervention Name(s)
Sutures only
Intervention Description
Traditional hiatal closure with non-absorbable sutures.
Primary Outcome Measure Information:
Title
Radiographic recurrence of PEH
Description
Computed tomography based recurrence after sutures only versus polyglactin mesh
Time Frame
6 months after surgery
Secondary Outcome Measure Information:
Title
Symptomatic versus asymptomatic recurrence rates
Description
Symptomatic versus asymptomatic recurrence rates based on symptoms and radiographic finding
Time Frame
6 months
Title
Reoperation rate
Description
Reoperation rate related to hiatal hernia recurrence
Time Frame
20 years
Title
Health related quality of life based on score in esophago-gastric questionnaire (EORTC qlq-og25)
Description
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.
Time Frame
6 months
Title
Hiatal defect size related to recurrence rate
Description
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)
Time Frame
6 months
Title
BMI and the risk of recurrence
Description
The correlation of BMI to recurrence rate (scatter plot with BMI in x-axis and recurrent hernias in y-axis)
Time Frame
6 months
Title
Proton pump inhibitor (PPI) use
Description
Use on proton pump inhibitors at 1- 3-, 5-, 10- and 20-years after surgery related to intervention method (sutures only or polyglactin mesh)
Time Frame
20 years
Title
Age and the risk of recurrence
Description
The correlation of age (years) to recurrence rate (scatter plot with age in x-axis and recurrent hernias in y-axis)
Time Frame
6 months
Title
Albumin level and the risk of recurrence
Description
The correlation of nutritional status (albumin level) to recurrence rate (scatter plot with albumin in x-axis and recurrent hernias in y-axis)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olli Helminen, MD, PhD
Phone
+35883152011
Email
olli.helminen@oulu.fi
Facility Information:
Facility Name
Oulu University Hospital
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olli Helminen, MD, PhD
Phone
+35883152011
Email
olli.helminen@oulu.fi

12. IPD Sharing Statement

Plan to Share IPD
No

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Sutures Versus Polyglactin Mesh in Hiatal Hernia Repair

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