Sutures Versus Polyglactin Mesh in Hiatal Hernia Repair

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

Tracking Information

• First Submitted Date: December 16, 2021
• First Posted Date: January 21, 2022
• Last Update Posted Date: March 27, 2023
• Actual Study Start Date: January 21, 2022
• Estimated Primary Completion Date: December 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 19, 2022)

Radiographic recurrence of PEH [ Time Frame: 6 months after surgery ]

Computed tomography based recurrence after sutures only versus polyglactin mesh

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 19, 2022)

• Symptomatic versus asymptomatic recurrence rates [ Time Frame: 6 months ]
  Symptomatic versus asymptomatic recurrence rates based on symptoms and radiographic finding
• Reoperation rate [ Time Frame: 20 years ]
  Reoperation rate related to hiatal hernia recurrence
• 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.
• 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)
• 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)
• 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)
• 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)
• 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)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Prospective open label randomized trial

Masking: None (Open Label)
Primary Purpose: Prevention

Condition

• Paraesophageal Hernia
• Hiatal Hernia
• Hiatal Hernia, Paraesophageal
• Recurrence

Intervention

• Procedure: Polyglactin mesh
  Polyglactin mesh is used in keyhole manner to enforce hiatal closure
• Procedure: Sutures only
  Traditional hiatal closure with non-absorbable sutures.

Study Arms

• Active Comparator: Sutures only
  Traditional suture closure of hiatal defect
  Intervention: Procedure: Sutures only
• Experimental: Polyglactin mesh
  In addition to traditional sutures, key hole polyglactin mesh for hiatal defect closure.
  Intervention: Procedure: Polyglactin mesh

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 19, 2022): 110
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 1, 2043
• Estimated Primary Completion Date: December 31, 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Finland

Administrative Information

• NCT Number: NCT05201508
• Other Study ID Numbers: Sutures or mesh for PEH
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Olli Helminen, Oulu University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Oulu University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Central Finland Hospital District
• Investigators: Not Provided
• PRS Account: Oulu University Hospital
• Verification Date: March 2023