Large Midline Ventral HerniaNCT03793738
Anterior Component Separation Versus Posterior Component Separation for Repair of Large Ventral Hernias
A study testing Anterior component separation and Posterior component separation in people with Large Midline Ventral Hernia, run by Zaza Demetrashvili at 1 site in Georgia.
Trial summary
This study evaluates effect of anterior component separation and posterior component separation and transversus abdominis muscle release methods for treatment of midline ventral hernias. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Large Midline Ventral Hernia
- What is being tested?
- Anterior component separation and Posterior component separation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGeorgia
- Study dates
- Dec 2016to Dec 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subject has midline ventral hernia
- patient's approval to participate in the study
Who cannot join
- strangulated hernia
- patient's preference for either operative technique
- patient's refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
Georgia1 site, 1 recruiting
- Recruiting
Tbilisi State Medical University
Tbilisi, 0186
Zaza Demetrashvili, zdemetr@yahoo.com
Zaza Demetrashvili
About this study
Official title: Anterior Component Separation Versus Posterior Component Separation for Repair of Large Ventral Hernias: a Prospective Cohort Study
This study evaluates effect of anterior component separation and posterior component separation and transversus abdominis muscle release methods for treatment of midline ventral hernias.
Read the detailed description
The anterior component separation technique requires an extensive subcutaneous flap elevation, incision of the external oblique aponeurosis, and incision of the posterior rectus sheath.
The posterior component separation technique utilized the retromuscular space, accessed by incising the posterior rectus sheath and dissecting the posterior sheath between the internal oblique and transversus abdominis muscles. Transversus abdominis muscle release dissected the posterior sheath back to the transversus abdominal muscle and accessed the space between muscle and trasversalis fascia.
- Conditions
- Large Midline Ventral Hernia
- Being tested
- Anterior component separation, Posterior component separation
- Keywords
- anterior component separation, TAR
- Medical subject headings
- Absent radii and thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior component separationProcedure or surgery
Posterior component separationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| anterior component separation | Active comparator | The anterior component separation technique requires an extensive subcutaneous flap elevation, incision of the external oblique aponeurosis, and incision of the posterior rectus sheath. Receives: Procedure: Anterior component separation |
| posterior component separation | Active comparator | The posterior component separation technique utilized the retromuscular space, accessed by incising the posterior rectus sheath and dissecting the posterior sheath between the internal oblique and transversus abdominis muscles. Receives: Procedure: Posterior component separation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hernia recurrence
Develop of ventral hernia recurrence
Measured: during 3 year after surgery
Secondary outcomes (1)
Wound complications
Develop of wound complications (seroma, hematoma, surgical site infection)
Measured: 30 day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study startDec 2016
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large Midline Ventral 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zaza Demetrashvili
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zaza Demetrashvili, Tbilisi State Medical University
- Investigators
- Zaza Demetrashvili, PhD, Principal investigator, Tbilisi State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793738
- Sponsor's protocol ID
- 01004006344
- Status last verified
- Oct 2022
- First submitted
- 27 Dec 2018
- Last updated
- 19 Oct 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Component Separation Versus Posterior Component Separation for Repair of Large Ventral Hernias: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03793738
- Acronym / sponsor ID
- 01004006344
- Conditions
- Large Midline Ventral Hernia
- Keywords
- anterior component separation, TAR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zaza DemetrashviliUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 4 Jan 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.
This study evaluates effect of anterior component separation and posterior component separation and transversus abdominis muscle release methods for treatment of midline ventral hernias.
Detailed description
The anterior component separation technique requires an extensive subcutaneous flap elevation, incision of the external oblique aponeurosis, and incision of the posterior rectus sheath.
The posterior component separation technique utilized the retromuscular space, accessed by incising the posterior rectus sheath and dissecting the posterior sheath between the internal oblique and transversus abdominis muscles. Transversus abdominis muscle release dissected the posterior sheath back to the transversus abdominal muscle and accessed the space between muscle and trasversalis fascia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anterior component separation | Active comparator | Procedure: Anterior component separationThe anterior component separation technique requires an extensive subcutaneous flap elevation, incision of the external oblique aponeurosis, and incision of the posterior rectus sheath. |
| posterior component separation | Active comparator | Procedure: Posterior component separationThe posterior component separation technique utilized the retromuscular space, accessed by incising the posterior rectus sheath and dissecting the posterior sheath between the internal oblique and transversus abdominis muscles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- subject has midline ventral hernia
- patient's approval to participate in the study
Key exclusion criteria (3 listed)
- strangulated hernia
- patient's preference for either operative technique
- patient's refusal to participate in the study
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 |
|---|---|---|
| Anterior component separation | Procedure or surgery | anterior component separation |
| Posterior component separation | Procedure or surgery | posterior component separation |
Primary outcome
Hernia recurrence
Time frame: during 3 year after surgery
Develop of ventral hernia recurrence
1 secondary outcome
Wound complications
Time frame: 30 day after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
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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.
Zaza Demetrashvili, PhD principal investigator
Tbilisi State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior component separation and Posterior component separation in people with Large Midline Ventral Hernia, run by Zaza Demetrashvili at 1 site in Georgia.
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 2 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: status not confirmed, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zaza Demetrashvili, MD, PhD (+995599217733, zdemetr@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hernia recurrence (time frame: during 3 year after surgery). 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 19 Oct 2022.