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.
Effect of Botox Injection on Lateral Abdominal Wall Muscles After Major Open Abdominal Surgery
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2020
CompletedFirst Posted
Study publicly available on registry
June 9, 2020
CompletedStudy Start
First participant enrolled
June 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 2, 2021
CompletedJune 18, 2020
December 1, 2019
1.5 years
June 3, 2020
June 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
incidence of incisional hernia.
incidence of incisional hernia.Effect of Botox injection on lateral abdominal wall muscles after major open abdominal surgery
one year
Study Arms (2)
Patients with ultrasound-guided botox injection
ACTIVE COMPARATOREffect of Botox injection on lateral abdominal wall muscles after major open abdominal surgery
Patients with no botox injection
ACTIVE COMPARATORPatients with major abdominal surgery without botox injection
Interventions
effect of botox injection in abdominal wall muscle post major abdominal surgery in terms of postoperative pain, incidence of incisional hernia.
surgery without botox injection
Eligibility Criteria
You may qualify if:
- Patients with major abdominal surgery including trauma and elective exploration surgery, damage control surgery.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura University
Al Mansurah, Dakahlia Governorate, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2020
First Posted
June 9, 2020
Study Start
June 16, 2020
Primary Completion
December 1, 2021
Study Completion
December 2, 2021
Last Updated
June 18, 2020
Record last verified: 2019-12