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 Overview
=================
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.

Official Title
-----------------
Effect of Botox Injection on Lateral Abdominal Wall Muscles After Major Open Abdominal Surgery

Conditions
-----------------
Hernia, Abdominal

Intervention / Treatment
-----------------
* Biological: Botox
* Procedure: surgery without botox injection


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients with ultrasound-guided botox injection<br>Effect of Botox injection on lateral abdominal wall muscles after major open abdominal surgery | Biological: Botox<br>* effect of botox injection in abdominal wall muscle post major abdominal surgery in terms of postoperative pain, incidence of incisional hernia.<br>|
| Active Comparator: Patients with no botox injection<br>Patients with major abdominal surgery without botox injection | Procedure: surgery without botox injection<br>* surgery without botox injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of incisional hernia. | incidence of incisional hernia.Effect of Botox injection on lateral abdominal wall muscles after major open abdominal surgery | one year |