ClinicalTrials.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has not verified this record recently (last verified Dec 2019), so the status shown — last known as Recruiting — may be out of date.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

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03

In context

Hernia, Abdominal

82 studies on the registry are indexed under Hernia, Abdominal; 19 are open to participants now.

This study's planned enrollment of 30 is below the median of 90 across 48 interventional studies indexed under Hernia, Abdominal.

Browse Hernia, Abdominal studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

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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

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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

07

Study locations

1 of 1 sites recruiting
  • Mansoura University
    Mansoura, Dakahlia, Egypt
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2020 (actual). Primary completion is estimated for Dec 2021, 17 months after the start.

Of 31 interventional studies with no phase under Hernia, Abdominal, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 60. This study's planned 17 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 3, 2020
First posted
Jun 9, 2020
StartActual
Jun 16, 2020
Primary completionEst.
Dec 1, 2021
CompletionEst.
Dec 2, 2021
Last update
Jun 18, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04422197
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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