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.

Not Applicable

• Conditions: Hernia, Abdominal
• Interventions: Procedure: surgery without botox injection; Biological: Botox

• Registration Number: NCT04422197
• Lead Sponsor: Mansoura University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2019-12
• Study First Submitted: 2020-06-03
• Study First Submitted QC: 2020-06-08
• Study First Posted: 2020-06-09
• Study Start: 2020-06-16
• Last Update Submitted: 2020-06-17
• Last Update Posted: 2020-06-18
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

-Patients with major abdominal surgery including trauma and elective exploration surgery, damage control surgery.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with no botox injection	surgery without botox injection	Patients with major abdominal surgery without botox injection
Patients with ultrasound-guided botox injection	Botox	Effect of Botox injection on lateral abdominal wall muscles after major open abdominal surgery

Primary Outcome Measures

Name	Time	Method
incidence of incisional hernia.	one year	incidence of incisional hernia.Effect of Botox injection on lateral abdominal wall muscles after major open abdominal surgery

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, Dakahlia, Egypt