Sutures Versus Polyglactin Mesh in Hiatal Hernia Repair

NCT05201508 | Recruiting

• 1 other identifier: Sutures or mesh for PEH
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Paraesophageal Hernia; Hiatal Hernia; Hiatal Hernia, Paraesophageal; Recurrence

Outcome Measures

Primary Outcomes (1)

• Radiographic recurrence of PEH

  Computed tomography based recurrence after sutures only versus polyglactin mesh

  6 months after surgery

Secondary Outcomes (8)

• Symptomatic versus asymptomatic recurrence rates

  6 months

• Reoperation rate

  20 years

• Health related quality of life based on score in esophago-gastric questionnaire (EORTC qlq-og25)

  6 months

• Hiatal defect size related to recurrence rate

  6 months

• BMI and the risk of recurrence

  6 months

Study Arms (2)

Sutures only

ACTIVE COMPARATOR

Traditional suture closure of hiatal defect

Procedure: Sutures only

Polyglactin mesh

EXPERIMENTAL

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

Procedure: Polyglactin mesh

Interventions

Polyglactin mesh PROCEDURE

Polyglactin mesh is used in keyhole manner to enforce hiatal closure

Polyglactin mesh

Sutures only PROCEDURE

Traditional hiatal closure with non-absorbable sutures.

Sutures only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years old
• Type III-IV PEH with either radiologic or endoscopic confirmation
• Scheduled for laparoscopic PEH repair
• The informed consent is acquired

You may not qualify if:

• Need for esophagus lengthening procedure (Collis gastroplasty)
• Recurrent PEH
• Emergency surgery
• No written consent

Sponsors & Collaborators

• Oulu University Hospital: lead
• Central Finland Hospital District: collaborator

Study Sites (1)

Oulu University Hospital

Oulu, 90220, Finland

RECRUITING

MeSH Terms

Conditions

Hernia, Hiatal; Recurrence

Condition Hierarchy (Ancestors)

Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Central Study Contacts

Olli Helminen, MD, PhD

CONTACT

+35883152011; olli.helminen@oulu.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Adjunct professor

Model Details: Prospective open label randomized trial

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 21, 2022
• Study Start: January 21, 2022
• Primary Completion: December 31, 2024
• Study Completion (Estimated): January 1, 2043
• Last Updated: March 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)