Approach to Hiatal Hernia Repair Based on Collagen Study

Grubnik Volodymyr

Status: Completed

Conditions: Hiatal Hernia; Gastroesophageal Reflux Disease

Treatments: Procedure: Laparoscopic hiatal hernia repair with ProGrip™ mesh; Procedure: Laparoscopic primary posterior crural repair

Study type: Interventional

Funder types: Other

Identifiers

NCT04152798

ONMedU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age older than 20 years
• Initially suffering from large hiatal hernia (>20% of the stomach in the thoracic cavity)
• Performance of laparoscopic hiatal hernia repair
• Informed Consent as documented by signature

Exclusion criteria

• Cases of conversion to open surgery
• Age < 20 years and > 80 years
• History of oesophageal/gastric/duodenal surgery including vagotomy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

ProGrip™ mesh repair

Active Comparator group

Description:

Laparoscopic hiatal hernia repair with ProGrip™ mesh

Treatment:

Procedure: Laparoscopic hiatal hernia repair with ProGrip™ mesh

Primary crural repair

Active Comparator group

Description:

Primary posterior crura repair

Treatment:

Procedure: Laparoscopic primary posterior crural repair