Hiatal HerniaNCT04152798
Approach to Hiatal Hernia Repair Based on Collagen Study
A study testing Laparoscopic hiatal hernia repair with ProGrip™ mesh and Laparoscopic primary posterior crural repair in people with Hiatal Hernia and Gastroesophageal Reflux Disease, run by Grubnik Volodymyr.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hiatal Hernia, Gastroesophageal Reflux Disease
- What is being tested?
- Laparoscopic hiatal hernia repair with ProGrip™ mesh and Laparoscopic primary posterior crural repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 20 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cases of conversion to open surgery
- Age < 20 years and > 80 years
- History of oesophageal/gastric/duodenal surgery including vagotomy
About this study
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.
Read the 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.
- Conditions
- Hiatal Hernia, Gastroesophageal Reflux Disease
- Being tested
- Laparoscopic hiatal hernia repair with ProGrip™ mesh, Laparoscopic primary posterior crural repair
- Medical subject headings
- Hernia, Hiatal, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic hiatal hernia repair with ProGrip™ meshProcedure or surgery
Also called Laparoscopic mesh hiatoplasty, Laparoscopic mesh hiatal closure
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 repairProcedure or surgery
Also called Laparoscopic posterior crurorrhaphy, Laparoscopic posterior crural closure
Posterior cruroraphy will be performed with 3 to 4 interrupted non-absorbable sutures
| Study group | Role | What they receive |
|---|---|---|
| ProGrip™ mesh repair | Active comparator | Laparoscopic hiatal hernia repair with ProGrip™ mesh Receives: Procedure: Laparoscopic hiatal hernia repair with ProGrip™ mesh |
| Primary crural repair | Active comparator | Primary posterior crura repair Receives: Procedure: Laparoscopic primary posterior crural repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate of hiatal hernia
Recurrence of hiatal hernia will be assessed by barium contrast swallow study
Measured: 36 months
Secondary outcomes (1)
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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start1 Jan 2014
- Primary completion20 Sep 2019
- Study completion20 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hiatal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grubnik Volodymyr
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Grubnik Volodymyr, Odessa National Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152798
- Sponsor's protocol ID
- ONMedU
- Status last verified
- Nov 2019
- First submitted
- 26 Oct 2019
- Last updated
- 7 Nov 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Approach to Hiatal Hernia Repair Based on Collagen Study
- ClinicalTrials.gov ID
- NCT04152798
- Acronym / sponsor ID
- ONMedU
- Conditions
- Hiatal Hernia, Gastroesophageal Reflux Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Grubnik VolodymyrUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ProGrip™ mesh repair | Active comparator | Procedure: Laparoscopic hiatal hernia repair with ProGrip™ meshLaparoscopic hiatal hernia repair with ProGrip™ mesh |
| Primary crural repair | Active comparator | Procedure: Laparoscopic primary posterior crural repairPrimary posterior crura repair |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Cases of conversion to open surgery
- Age < 20 years and > 80 years
- History of oesophageal/gastric/duodenal surgery including vagotomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic hiatal hernia repair with ProGrip™ meshAlso: Laparoscopic mesh hiatoplasty, Laparoscopic mesh hiatal closureSuturing of the right and left diaphragmatic crura using 3 to 4 interrupted nonabsorbable stitches with additional reinforcement of crura repair with ProGrip™ mesh | Procedure or surgery | ProGrip™ mesh repair |
| Laparoscopic primary posterior crural repairAlso: Laparoscopic posterior crurorrhaphy, Laparoscopic posterior crural closurePosterior cruroraphy will be performed with 3 to 4 interrupted non-absorbable sutures | Procedure or surgery | Primary crural repair |
Primary outcome
Recurrence rate of hiatal hernia
Time frame: 36 months
Recurrence of hiatal hernia will be assessed by barium contrast swallow study
1 secondary outcome
Quality of life and satisfaction
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic hiatal hernia repair with ProGrip™ mesh and Laparoscopic primary posterior crural repair in people with Hiatal Hernia and Gastroesophageal Reflux Disease, run by Grubnik Volodymyr.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate of hiatal hernia (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2019; AzTrials last refreshed its copy on 6 Nov 2026.