Sutures Versus Polyglactin Mesh in Hiatal Hernia Repair

Not Applicable

Recruiting

• Conditions: Hiatal Hernia; Hiatal Hernia, Paraesophageal; Paraesophageal Hernia; Recurrence

• Registration Number: NCT05201508
• Lead Sponsor: Oulu University Hospital

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 available

Study Timeline

• Study First Submitted: 2021-12-16
• Study First Submitted QC: 2022-01-19
• Study Start: 2022-01-21
• Study First Posted: 2022-01-21
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-24
• Last Update Posted: 2023-03-27
• Primary Completion: 2024-12-31
• Study Completion: 2043-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Radiographic recurrence of PEH	6 months after surgery	Computed tomography based recurrence after sutures only versus polyglactin mesh

Secondary Outcome Measures

Name	Time	Method
Reoperation rate	20 years	Reoperation rate related to hiatal hernia recurrence
Health related quality of life based on score in esophago-gastric questionnaire (EORTC qlq-og25)	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.
BMI and the risk of recurrence	6 months	The correlation of BMI to recurrence rate (scatter plot with BMI in x-axis and recurrent hernias in y-axis)
Age and the risk of recurrence	6 months	The correlation of age (years) to recurrence rate (scatter plot with age in x-axis and recurrent hernias in y-axis)
Hiatal defect size related to recurrence rate	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)
Symptomatic versus asymptomatic recurrence rates	6 months	Symptomatic versus asymptomatic recurrence rates based on symptoms and radiographic finding
Proton pump inhibitor (PPI) use	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)
Albumin level and the risk of recurrence	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)

Trial Locations

Locations (1)

Oulu University Hospital; 🇫🇮 Oulu, Finland