Clinical trial NCT05201508: 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
Overall status: RECRUITING
Phase: NA
Conditions: Paraesophageal Hernia
Hiatal Hernia
Hiatal Hernia, Paraesophageal
Recurrence
Lead sponsor: Oulu University Hospital
Sponsor class: OTHER
Collaborators: name: Central Finland Hospital District
First posted: 2022-01-21
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective open label randomized trial
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Radiographic recurrence of PEH
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Symptomatic versus asymptomatic recurrence rates
timeFrame: 6 months
measure: Reoperation rate
timeFrame: 20 years
measure: Health related quality of life based on score in esophago-gastric questionnaire (EORTC qlq-og25)
timeFrame: 6 months
measure: Hiatal defect size related to recurrence rate
timeFrame: 6 months
measure: BMI and the risk of recurrence
timeFrame: 6 months
measure: Proton pump inhibitor (PPI) use
timeFrame: 20 years
measure: Age and the risk of recurrence
timeFrame: 6 months
measure: Albumin level and the risk of recurrence
timeFrame: 6 months
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
References: