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Sutures Versus Polyglactin Mesh in Hiatal Hernia Repair

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ClinicalTrials.gov Identifier: NCT05201508
Recruitment Status : Recruiting
First Posted : January 21, 2022
Last Update Posted : March 27, 2023
Sponsor:
Collaborator:
Central Finland Hospital District
Information provided by (Responsible Party):
Olli Helminen, Oulu University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Paraesophageal Hernia Hiatal Hernia Hiatal Hernia, Paraesophageal Recurrence Procedure: Polyglactin mesh Procedure: Sutures only Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective open label randomized trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Sutures Only Versus Absorbable Polyglactin (Vicryl®) Mesh in Closure of Hiatal Defect in Laparoscopic Paraesophageal Hernia Repair: Randomized Controlled Trial.
Actual Study Start Date : January 21, 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : January 1, 2043

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Radiographic recurrence of PEH [ Time Frame: 6 months after surgery ]
    Computed tomography based recurrence after sutures only versus polyglactin mesh


Secondary Outcome Measures :
  1. Symptomatic versus asymptomatic recurrence rates [ Time Frame: 6 months ]
    Symptomatic versus asymptomatic recurrence rates based on symptoms and radiographic finding

  2. Reoperation rate [ Time Frame: 20 years ]
    Reoperation rate related to hiatal hernia recurrence

  3. Health related quality of life based on score in esophago-gastric questionnaire (EORTC qlq-og25) [ Time Frame: 6 months ]
    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.

  4. Hiatal defect size related to recurrence rate [ Time Frame: 6 months ]
    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)

  5. BMI and the risk of recurrence [ Time Frame: 6 months ]
    The correlation of BMI to recurrence rate (scatter plot with BMI in x-axis and recurrent hernias in y-axis)

  6. Proton pump inhibitor (PPI) use [ Time Frame: 20 years ]
    Use on proton pump inhibitors at 1- 3-, 5-, 10- and 20-years after surgery related to intervention method (sutures only or polyglactin mesh)

  7. Age and the risk of recurrence [ Time Frame: 6 months ]
    The correlation of age (years) to recurrence rate (scatter plot with age in x-axis and recurrent hernias in y-axis)

  8. Albumin level and the risk of recurrence [ Time Frame: 6 months ]
    The correlation of nutritional status (albumin level) to recurrence rate (scatter plot with albumin in x-axis and recurrent hernias in y-axis)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05201508


Contacts
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Contact: Olli Helminen, MD, PhD +35883152011 olli.helminen@oulu.fi

Locations
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Finland
Oulu University Hospital Recruiting
Oulu, Finland, 90220
Contact: Olli Helminen, MD, PhD    +35883152011    olli.helminen@oulu.fi   
Sponsors and Collaborators
Oulu University Hospital
Central Finland Hospital District
More Information
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Responsible Party: Olli Helminen, MD, PhD, Adjunct professor, Oulu University Hospital
ClinicalTrials.gov Identifier: NCT05201508    
Other Study ID Numbers: Sutures or mesh for PEH
First Posted: January 21, 2022    Key Record Dates
Last Update Posted: March 27, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hernia
Recurrence
Hernia, Hiatal
Pathological Conditions, Anatomical
 Disease Attributes
Pathologic Processes
Hernia, Diaphragmatic
Internal Hernia