Back to resultsApproach to Hiatal Hernia Repair Based on Collagen Study
Primary Purpose
Hiatal Hernia, Gastroesophageal Reflux Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laparoscopic hiatal hernia repair with ProGrip™ mesh
Laparoscopic primary posterior crural repair
Sponsored by
About this trial
This is an interventional treatment trial for Hiatal Hernia
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
ProGrip™ mesh repair
Primary crural repair
Arm Description
Laparoscopic hiatal hernia repair with ProGrip™ mesh
Primary posterior crura repair
Outcomes
Primary Outcome Measures
Recurrence rate of hiatal hernia
Recurrence of hiatal hernia will be assessed by barium contrast swallow study
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04152798
Brief Title
Approach to Hiatal Hernia Repair Based on Collagen Study
Official Title
Approach to Hiatal Hernia Repair Based on Collagen Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2014 (Actual)
Primary Completion Date
September 20, 2019 (Actual)
Study Completion Date
September 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Grubnik Volodymyr
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hiatal Hernia, Gastroesophageal Reflux Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ProGrip™ mesh repair
Arm Type
Active Comparator
Arm Description
Laparoscopic hiatal hernia repair with ProGrip™ mesh
Arm Title
Primary crural repair
Arm Type
Active Comparator
Arm Description
Primary posterior crura repair
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic hiatal hernia repair with ProGrip™ mesh
Other Intervention Name(s)
Laparoscopic mesh hiatoplasty, Laparoscopic mesh hiatal closure
Intervention Description
Suturing of the right and left diaphragmatic crura using 3 to 4 interrupted nonabsorbable stitches with additional reinforcement of crura repair with ProGrip™ mesh
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic primary posterior crural repair
Other Intervention Name(s)
Laparoscopic posterior crurorrhaphy, Laparoscopic posterior crural closure
Intervention Description
Posterior cruroraphy will be performed with 3 to 4 interrupted non-absorbable sutures
Primary Outcome Measure Information:
Title
Recurrence rate of hiatal hernia
Description
Recurrence of hiatal hernia will be assessed by barium contrast swallow study
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Quality of life and satisfaction
Description
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.
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
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Approach to Hiatal Hernia Repair Based on Collagen Study
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