Sutures Versus Polyglactin Mesh in Hiatal Hernia Repair

Recurrence Clinical Trial

Official title:

Sutures Only Versus Absorbable Polyglactin (Vicryl®) Mesh in Closure of Hiatal Defect in Laparoscopic Paraesophageal Hernia Repair: Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05201508
• Other study ID #: Sutures or mesh for PEH
• Status: Recruiting
• Phase: N/A
• Start date: January 21, 2022
• Est. completion date: January 1, 2043

Study information

• Verified date: March 2023
• Source: Oulu University Hospital
• Contact: Olli Helminen, MD, PhD
• Phone: +35883152011
• Email: olli.helminen[@]oulu.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: January 1, 2043
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Finland	Oulu University Hospital	Oulu

Sponsors (2)

Lead Sponsor	Collaborator
Oulu University Hospital	Central Finland Hospital District

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic recurrence of PEH	Computed tomography based recurrence after sutures only versus polyglactin mesh	6 months after surgery
Secondary	Symptomatic versus asymptomatic recurrence rates	Symptomatic versus asymptomatic recurrence rates based on symptoms and radiographic finding	6 months
Secondary	Reoperation rate	Reoperation rate related to hiatal hernia recurrence	20 years
Secondary	Health related quality of life based on score in esophago-gastric questionnaire (EORTC qlq-og25)	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.	6 months
Secondary	Hiatal defect size related to recurrence rate	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)	6 months
Secondary	BMI and the risk of recurrence	The correlation of BMI to recurrence rate (scatter plot with BMI in x-axis and recurrent hernias in y-axis)	6 months
Secondary	Proton pump inhibitor (PPI) use	Use on proton pump inhibitors at 1- 3-, 5-, 10- and 20-years after surgery related to intervention method (sutures only or polyglactin mesh)	20 years
Secondary	Age and the risk of recurrence	The correlation of age (years) to recurrence rate (scatter plot with age in x-axis and recurrent hernias in y-axis)	6 months
Secondary	Albumin level and the risk of recurrence	The correlation of nutritional status (albumin level) to recurrence rate (scatter plot with albumin in x-axis and recurrent hernias in y-axis)	6 months