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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04422197
Other study ID # R.19.05.515
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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