NCT04152798

Approach to Hiatal Hernia Repair Based on Collagen Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Grubnik Volodymyr · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Groups of patients who underwent laparoscopic repair of large hiatal hernias by primary posterior crural repair and crural repair with ProGrip™ mesh techniques were examined for recurrence rate of hiatal hernias, quality of life according to the GERD-HRQL questionnaire. Clinical evaluation was performed at 3, 6, 12, 24, 36, and 48 months after surgery.

Detailed description

The laparoscopic repair of large hiatal hernias is mostly performed by cruroraphy or cruroraphy with mesh reinforcement techniques. Cruroraphy it is suturing of the right and left diaphragmatic crura using nonabsorbable stitches. Main disadvantage of such technique is the high hiatal hernia recurrence rate after surgery. Cruroraphy with mesh reinforcement technique followed by relatively less hiatal hernia recurrence rate but associated with a large number of mesh-related complications.

Conditions

• Hiatal Hernia
• Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic hiatal hernia repair with ProGrip™ mesh	Suturing of the right and left diaphragmatic crura using 3 to 4 interrupted nonabsorbable stitches with additional reinforcement of crura repair with ProGrip™ mesh
PROCEDURE	Laparoscopic primary posterior crural repair	Posterior cruroraphy will be performed with 3 to 4 interrupted non-absorbable sutures

Timeline

• Start date: 2014-01-01
• Primary completion: 2019-09-20
• Completion: 2019-09-20
• First posted: 2019-11-05
• Last updated: 2019-11-07