CClinicalTrials.gg
Status unknownNCT04422197Updated Jun 18, 2020

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.

An interventional study of Botox and surgery without botox injection in Hernia, Abdominal, sponsored by Mansoura University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-06-18.

Sponsored by Mansoura University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Dec 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hernia, Abdominal
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Patients with ultrasound-guided botox injection

    Effect of Botox injection on lateral abdominal wall muscles after major open abdominal surgery

    Biological: Botox

  • Active comparator
    Patients with no botox injection

    Patients with major abdominal surgery without botox injection

    Procedure: surgery without botox injection

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

05

What researchers measure

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

    Time frame: one year

06

Study locations

1 of 1 sites recruiting
  • Mansoura University
    Mansoura, Dakahlia, Egypt
    Recruiting
07

Registry details

Key details

Study ID
NCT04422197
Lead sponsor
Mansoura University
Responsible party
Sponsor
First posted
Jun 9, 2020
Start date
Jun 16, 2020
Primary completion
Dec 1, 2021 (estimated)
Completion
Dec 2, 2021 (estimated)
Last update
Jun 18, 2020

Study contacts

Mohamed Arnouse
Contact
drmhamdy@mans.edu.eg
01099222561
Mahmoud Abdelnaby
Contact
Abdelshafymahmoud@gmail.com
01099222561

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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