TAR TechniqueNCT04419844
Evaluation of TAR Technique in the Treatment of Huge Abdominal Wall Hernia and Large Abdominal Wall Defect With or Without Botox Injection .
A study testing Tar with Botox in people with TAR Technique, run by Mansoura University at 1 site in Egypt.
Trial summary
Aim of the work In this study, we will evaluate posterior component separation (TAR) technique with or without Botox injection for open huge ventral hernia and large abdominal wall defect repair. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- TAR Technique
- What is being tested?
- Tar with Botox
- 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 siteEgypt
- Study dates
- 17 Jun 2020to 2 Jun 2021
- 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 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult patient fit for general anesthesia with huge ventral hernia (primary, incisional or recurrent).Any patient with large abdominal wall defect secondary to abdominal wall tumor excision or burst after surgery
Who cannot join
- Patients who are unfit for general anaesthesia. Poor pulmonary function tests. Pregnant females. Patient younger than 18 years. Immunodeficiency. Patient with psychiatric disease disabling surgical intervention. Patients who refuse to participate in our study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University
Al Mansurah, Dakahlia Governorate
Mohamed Hamada Mohamed Hamada, +20 109 212 7930, irb.mfm@hotmail.com
About this study
Aim of the work In this study, we will evaluate posterior component separation (TAR) technique with or without Botox injection for open huge ventral hernia and large abdominal wall defect repair. The primary outcome will be recurrence while the secondary outcome will be infection, postoperative complications (bleeding and dehiscence), pain score, operative time, hospitalization, need for drain, time for drain removal and pulmonary function test before and after surgery.
This prospective clinical study will be performed on 40 eligible patients admitted to general surgery department at Mansoura University Hospi
- Conditions
- TAR Technique
- Being tested
- Tar with Botox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tar with BotoxProcedure or surgery
Evaluation of TAR technique in the treatment of huge abdominal wall hernia and large abdominal wall defect with Botox injection .
| Study group | Role | What they receive |
|---|---|---|
| TAR with Botox | Active comparator | Evaluation of TAR technique in the treatment of huge abdominal wall hernia and large abdominal wall defect Botox injection . Receives: Procedure: Tar with Botox |
| TAR without Botox | Active comparator | Evaluation of TAR technique in the treatment of huge abdominal wall hernia and large abdominal wall defect without Botox injection . Receives: Procedure: Tar with Botox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
Recurrence of the ventral hernia
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start17 Jun 2020
- Primary completion1 Jun 2021 (estimated)
- Study completion2 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TAR TechniqueStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419844
- Sponsor's protocol ID
- R.19.03.451 - 2019/03/11
- Status last verified
- May 2020
- First submitted
- 3 Jun 2020
- Last updated
- 18 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of TAR Technique in the Treatment of Huge Abdominal Wall Hernia and Large Abdominal Wall Defect With or Without Botox Injection .
- ClinicalTrials.gov ID
- NCT04419844
- Acronym / sponsor ID
- R.19.03.451 - 2019/03/11
- Conditions
- TAR Technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 17 Jun 2020 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 2 Jun 2021 (estimated)
- First posted
- 5 Jun 2020 (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.
Aim of the work In this study, we will evaluate posterior component separation (TAR) technique with or without Botox injection for open huge ventral hernia and large abdominal wall defect repair. The primary outcome will be recurrence while the secondary outcome will be infection, postoperative complications (bleeding and dehiscence), pain score, operative time, hospitalization, need for drain, time for drain removal and pulmonary function test before and after surgery.
This prospective clinical study will be performed on 40 eligible patients admitted to general surgery department at Mansoura University Hospi
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAR with Botox | Active comparator | Procedure: Tar with BotoxEvaluation of TAR technique in the treatment of huge abdominal wall hernia and large abdominal wall defect Botox injection . |
| TAR without Botox | Active comparator | Procedure: Tar with BotoxEvaluation of TAR technique in the treatment of huge abdominal wall hernia and large abdominal wall defect without Botox injection . |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patient fit for general anesthesia with huge ventral hernia (primary, incisional or recurrent).Any patient with large abdominal wall defect secondary to abdominal wall tumor excision or burst after surgery
Key exclusion criteria (1 listed)
- Patients who are unfit for general anaesthesia. Poor pulmonary function tests. Pregnant females. Patient younger than 18 years. Immunodeficiency. Patient with psychiatric disease disabling surgical intervention. Patients who refuse to participate in our 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 |
|---|---|---|
| Tar with BotoxEvaluation of TAR technique in the treatment of huge abdominal wall hernia and large abdominal wall defect with Botox injection . | Procedure or surgery | TAR with Botox, TAR without Botox |
Primary outcome
Recurrence
Time frame: one year
Recurrence of the ventral hernia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tar with Botox in people with TAR Technique, run by Mansoura University at 1 site in Egypt.
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 1 inclusion and 1 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 18 Jun 2020. 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 Egypt. 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 Mohamed Arnouse (01099222561, drmhamdy@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence (time frame: one year). 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 18 Jun 2020.