Back to resultsThis 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.
Primary Purpose
Hernia, Abdominal
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Botox
surgery without botox injection
Sponsored by
About this trial
This is an interventional prevention trial for Hernia, Abdominal
Eligibility Criteria
Inclusion Criteria:
-Patients with major abdominal surgery including trauma and elective exploration surgery, damage control surgery.
Exclusion Criteria:
- 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
- patients with psychiatric disorders
- patients with drug abuse or history of opioid intake
- chronic pain disorder
- coagulopathy
Sites / Locations
- Mansoura UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Patients with ultrasound-guided botox injection
Patients with no botox injection
Arm Description
Effect of Botox injection on lateral abdominal wall muscles after major open abdominal surgery
Patients with major abdominal surgery without botox injection
Outcomes
Primary Outcome Measures
incidence of incisional hernia.
incidence of incisional hernia.Effect of Botox injection on lateral abdominal wall muscles after major open abdominal surgery
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04422197
Brief Title
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.
Official Title
Effect of Botox Injection on Lateral Abdominal Wall Muscles After Major Open Abdominal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 16, 2020 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
December 2, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Abdominal
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with ultrasound-guided botox injection
Arm Type
Active Comparator
Arm Description
Effect of Botox injection on lateral abdominal wall muscles after major open abdominal surgery
Arm Title
Patients with no botox injection
Arm Type
Active Comparator
Arm Description
Patients with major abdominal surgery without botox injection
Intervention Type
Biological
Intervention Name(s)
Botox
Intervention Description
effect of botox injection in abdominal wall muscle post major abdominal surgery in terms of postoperative pain, incidence of incisional hernia.
Intervention Type
Procedure
Intervention Name(s)
surgery without botox injection
Intervention Description
surgery without botox injection
Primary Outcome Measure Information:
Title
incidence of incisional hernia.
Description
incidence of incisional hernia.Effect of Botox injection on lateral abdominal wall muscles after major open abdominal surgery
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-Patients with major abdominal surgery including trauma and elective exploration surgery, damage control surgery.
Exclusion Criteria:
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
patients with psychiatric disorders
patients with drug abuse or history of opioid intake
chronic pain disorder
coagulopathy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Arnouse
Phone
01099222561
Email
drmhamdy@mans.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud Abdelnaby
Phone
01099222561
Email
Abdelshafymahmoud@gmail.com
Facility Information:
Facility Name
Mansoura University
City
Mansoura
State/Province
Dakahlia
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Hamada Mohamed Hamada
Phone
+20 109 212 7930
Email
irb.mfm@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
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.
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