Effect Of High-Intensity Focused Ultrasound On Abdominal Skin Laxity Post Sleeve Gastrectomy
NCT ID: NCT05994079
Last Updated: 2023-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
86 participants
INTERVENTIONAL
2022-06-20
2022-12-20
Brief Summary
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Detailed Description
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This study carried out to investigate the effectiveness of High-intensity focused ultrasound (HIFU) in treatment of abdominal skin laxity post sleeve gastrectomy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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high intensity focused ultrasound group
This group includes 43 patients who have abdominal skin laxity post sleeve gastrectomy and who will receive high intensity focused ultrasound. patients will receive one session; time of session is 40 minutes.
High intensity focused ultrasound
Parameters:
Transducer frequency 7-2-mhz 1.5-9.0-mm focal depth. The pulse duration for each individual exposure ranged from 25 to 40 milliseconds.
Energy per ultrasound pulse ranged from 1.0 to 1.5 J
medical topical firming creams group
This group includes 43 patients who have abdominal skin laxity post sleeve gastrectomy and who will receive medical topical firming creams.
topical firming creams
medical topical firming creams
Interventions
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High intensity focused ultrasound
Parameters:
Transducer frequency 7-2-mhz 1.5-9.0-mm focal depth. The pulse duration for each individual exposure ranged from 25 to 40 milliseconds.
Energy per ultrasound pulse ranged from 1.0 to 1.5 J
topical firming creams
medical topical firming creams
Eligibility Criteria
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Inclusion Criteria
* Age range between 30-45 years.
* Female patients will participate in the study.
* All patients will have post sleeve gastrectomy abdominal skin laxity mild to moderate degree according to skin laxity scale Randomized images were evaluated by three clinical specialists for the degree of skin laxity (0-3 scale; 0 = no laxity, 1 = mild, 2 = moderate, 3 = severe).
* All patients enrolled to the study will have their informed consent.
Exclusion Criteria
* Age more than 45 years or less than 30 years.
* Patients have acute viral diseases, acute tuberculosis, mental disorders
* Older people with more extensive photo-aging, severe skin laxity.
* Open skin lesions at the target area.
* Severe or cystic acne.
* Metallic implants in the treatment area.
* Genetic disease
* Skin infectious diseases.
* Sociological diseases.
* Pregnant.
30 Years
45 Years
FEMALE
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Rania Hassan Kamel Abdelkader El-Hawary
Principal Investigator
Principal Investigators
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Rania Elhawary
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Locations
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Outpatient clinic faculty of physical therapy cairo university
Dokki, , Egypt
Countries
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Other Identifiers
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012/003743
Identifier Type: -
Identifier Source: org_study_id
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