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.

Hernia, Abdominal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04422197
• Other study ID #: R.19.05.515
• Status: Recruiting
• Phase: N/A
• Start date: June 16, 2020
• Est. completion date: December 2, 2021

Study information

• Verified date: December 2019
• Source: Mansoura University
• Contact: Mohamed Arnouse
• Phone: 01099222561
• Email: drmhamdy[@]mans.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Abdominal

Intervention

Biological:
• Botox
effect of botox injection in abdominal wall muscle post major abdominal surgery in terms of postoperative pain, incidence of incisional hernia.

Procedure:
• surgery without botox injection
surgery without botox injection

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of incisional hernia.	incidence of incisional hernia.Effect of Botox injection on lateral abdominal wall muscles after major open abdominal surgery	one year