Approach to Hiatal Hernia Repair Based on Collagen Study
1 other identifier
interventional
140
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2014
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2019
CompletedFirst Submitted
Initial submission to the registry
October 26, 2019
CompletedFirst Posted
Study publicly available on registry
November 5, 2019
CompletedNovember 7, 2019
November 1, 2019
5.7 years
October 26, 2019
November 5, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Recurrence rate of hiatal hernia
Recurrence of hiatal hernia will be assessed by barium contrast swallow study
36 months
Secondary Outcomes (1)
Quality of life and satisfaction
36 months
Study Arms (2)
ProGrip™ mesh repair
ACTIVE COMPARATORLaparoscopic hiatal hernia repair with ProGrip™ mesh
Primary crural repair
ACTIVE COMPARATORPrimary posterior crura repair
Interventions
Suturing of the right and left diaphragmatic crura using 3 to 4 interrupted nonabsorbable stitches with additional reinforcement of crura repair with ProGrip™ mesh
Posterior cruroraphy will be performed with 3 to 4 interrupted non-absorbable sutures
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Cases of conversion to open surgery
- Age \< 20 years and \> 80 years
- History of oesophageal/gastric/duodenal surgery including vagotomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, Professor
Study Record Dates
First Submitted
October 26, 2019
First Posted
November 5, 2019
Study Start
January 1, 2014
Primary Completion
September 20, 2019
Study Completion
September 20, 2019
Last Updated
November 7, 2019
Record last verified: 2019-11