Approach to Hiatal Hernia Repair Based on Collagen Study

Not Applicable

Completed

• Conditions: Hiatal Hernia; Gastroesophageal Reflux Disease
• Interventions: Procedure: Laparoscopic primary posterior crural repair; Procedure: Laparoscopic hiatal hernia repair with ProGrip™ mesh

• Registration Number: NCT04152798
• Lead Sponsor: Grubnik Volodymyr

Brief 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.

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2019-09-20
• Study Completion: 2019-09-20
• Study First Submitted: 2019-10-26
• Status Verified: 2019-11
• Study First Submitted QC: 2019-11-04
• Study First Posted: 2019-11-05
• Last Update Submitted: 2019-11-05
• Last Update Posted: 2019-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primary crural repair	Laparoscopic primary posterior crural repair	Primary posterior crura repair
ProGrip™ mesh repair	Laparoscopic hiatal hernia repair with ProGrip™ mesh	Laparoscopic hiatal hernia repair with ProGrip™ mesh

Primary Outcome Measures

Name	Time	Method
Recurrence rate of hiatal hernia	36 months	Recurrence of hiatal hernia will be assessed by barium contrast swallow study

Secondary Outcome Measures

Name	Time	Method
Quality of life and satisfaction	36 months	Quality of life and satisfaction will be assessed by Gastroesophageal reflux disease - health-related quality of life (GERD-HRQL) score. The scale has 11 items,each item is scored from 0 to 5. A higher score indicating a better quality of life.