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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04422197
Enrollment
30
Registered
2020-06-09
Start date
2020-06-16
Completion date
2021-12-02
Last updated
2020-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hernia, Abdominal

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.

Interventions

BIOLOGICALBotox

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

PROCEDUREsurgery without botox injection

surgery without botox injection

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
incidence of incisional hernia.one yearincidence of incisional hernia.Effect of Botox injection on lateral abdominal wall muscles after major open abdominal surgery

Countries

Egypt

Contacts

Primary ContactMohamed Arnouse
drmhamdy@mans.edu.eg01099222561
Backup ContactMahmoud Abdelnaby
Abdelshafymahmoud@gmail.com01099222561

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026