Approach to Hiatal Hernia Repair Based on Collagen Study

Gastroesophageal Reflux Disease Clinical Trial

Official title:

Approach to Hiatal Hernia Repair Based on Collagen Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04152798
• Other study ID #: ONMedU
• Status: Completed
• Phase: N/A
• Start date: January 1, 2014
• Est. completion date: September 20, 2019

Study information

• Verified date: November 2019
• Source: Odessa National Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: September 20, 2019
• Est. primary completion date: September 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• Hernia
• Hernia, Hiatal
• Hiatal Hernia

Intervention

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
• Laparoscopic primary posterior crural repair
Posterior cruroraphy will be performed with 3 to 4 interrupted non-absorbable sutures

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Grubnik Volodymyr

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rate of hiatal hernia	Recurrence of hiatal hernia will be assessed by barium contrast swallow study	36 months
Secondary	Quality of life and satisfaction	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.	36 months