Hernia, AbdominalNCT04422197
This Randomized Controlled Study Aims to Investigate the Effect of Botox Injection in Abdominal Wall Muscle Post Major Abdominal Surgery in Terms of Postoperative Pain, Incidence of Incisional Hernia.
A study testing Botox and surgery without botox injection in people with Hernia, Abdominal, run by Mansoura University at 1 site in Egypt.
Trial summary
Aim of the work This randomized controlled study aims to investigate the effect of botox injection in abdominal wall muscle post major abdominal surgery in terms of postoperative pain, incidence of incisional hernia Study design and setting This is a double-blind prospective randomized controlled trial that will be… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hernia, Abdominal
- What is being tested?
- Botox and surgery without botox injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Jun 2020to 2 Dec 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Patients with major abdominal surgery including trauma and elective exploration surgery, damage control surgery.
Who cannot join
- pregnancy
- patients with myopathies
- motor polyneuropathies, impaired neuromuscular transmission (Myasthenia Gravis)
- complicated Chronic Obstructive Pulmonary Disease (COPD),
- necrotizing fasciitis of the trunk
- unfit for general anesthesia
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- patients with psychiatric disorders
- patients with drug abuse or history of opioid intake
- chronic pain disorder
- coagulopathy
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
Official title: Effect of Botox Injection on Lateral Abdominal Wall Muscles After Major Open Abdominal Surgery
Aim of the work This randomized controlled study aims to investigate the effect of botox injection in abdominal wall muscle post major abdominal surgery in terms of postoperative pain, incidence of incisional hernia Study design and setting This is a double-blind prospective randomized controlled trial that will be conducted in the general surgery department and colorectal surgery unit of Mansoura University hospital in the period from June 2019 to June2020. The patient's recruitment process will be started and continued for one year after getting the approval from the local Institutional Review Board in Mansoura University in concordance with the Helsinki Declaration Principals. The data will be collected and analyzed prospectively. A signed informed consent will be obtained from every patient before enrollment highlighting the possible future publication. On request, patients can be excluded from the study at any time if they do not want to continue.
- Conditions
- Hernia, Abdominal
- Being tested
- Botox, surgery without botox injection
- Medical subject headings
- Hernia, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BotoxBiological
effect of botox injection in abdominal wall muscle post major abdominal surgery in terms of postoperative pain, incidence of incisional hernia.
surgery without botox injectionProcedure or surgery
surgery without botox injection
| Study group | Role | What they receive |
|---|---|---|
| Patients with ultrasound-guided botox injection | Active comparator | Effect of Botox injection on lateral abdominal wall muscles after major open abdominal surgery Receives: Biological: Botox |
| Patients with no botox injection | Active comparator | Patients with major abdominal surgery without botox injection Receives: Procedure: surgery without botox injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of incisional hernia.
incidence of incisional hernia.Effect of Botox injection on lateral abdominal wall muscles after major open abdominal surgery
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 posted9 Jun 2020
- Study start16 Jun 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion2 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, AbdominalStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT04422197
- Sponsor's protocol ID
- R.19.05.515
- Status last verified
- Dec 2019
- 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
- Effect of Botox Injection on Lateral Abdominal Wall Muscles After Major Open Abdominal Surgery
- ClinicalTrials.gov ID
- NCT04422197
- Acronym / sponsor ID
- R.19.05.515
- Conditions
- Hernia, Abdominal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 2 Dec 2021 (estimated)
- First posted
- 9 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 This randomized controlled study aims to investigate the effect of botox injection in abdominal wall muscle post major abdominal surgery in terms of postoperative pain, incidence of incisional hernia Study design and setting This is a double-blind prospective randomized controlled trial that will be conducted in the general surgery department and colorectal surgery unit of Mansoura University hospital in the period from June 2019 to June2020. The patient's recruitment process will be started and continued for one year after getting the approval from the local Institutional Review Board in Mansoura University in concordance with the Helsinki Declaration Principals. The data will be collected and analyzed prospectively. A signed informed consent will be obtained from every patient before enrollment highlighting the possible future publication. On request, patients can be excluded from the study at any time if they do not want to continue.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with ultrasound-guided botox injection | Active comparator | Biological: BotoxEffect of Botox injection on lateral abdominal wall muscles after major open abdominal surgery |
| Patients with no botox injection | Active comparator | Procedure: surgery without botox injectionPatients with major abdominal surgery without botox injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Patients with major abdominal surgery including trauma and elective exploration surgery, damage control surgery.
Key exclusion criteria (10 listed)
- pregnancy
- patients with myopathies
- motor polyneuropathies, impaired neuromuscular transmission (Myasthenia Gravis)
- complicated Chronic Obstructive Pulmonary Disease (COPD),
- necrotizing fasciitis of the trunk
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 |
|---|---|---|
| Botoxeffect of botox injection in abdominal wall muscle post major abdominal surgery in terms of postoperative pain, incidence of incisional hernia. | Biological | Patients with ultrasound-guided botox injection |
| surgery without botox injectionsurgery without botox injection | Procedure or surgery | Patients with no botox injection |
Primary outcome
incidence of incisional hernia.
Time frame: one year
incidence of incisional hernia.Effect of Botox injection on lateral abdominal wall muscles after major open abdominal surgery
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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botox and surgery without botox injection in people with Hernia, Abdominal, 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 10 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?
incidence of incisional hernia. (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.