- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07051759
- Original Trial
Back Rolls Assessment (Back rolls)
Assessment of Back Rolls and Algorithm of Management
"Back Rolls" are basically fat deposits on the back in the form of rolls. This is a common problem in women, and concerns were encountered by cosmetic surgeons the worldwide. Deep connective tissue in the back attachments to the underlying muscle and/or periosteum divide the fat deposits on the back into multiple visual compartments. Their nomenclature is based on the anatomical area from where they have originated. The skin-fat envelope is held in place by facial attachments that are named the "zones of adherence".
The extent of fat deposits and number of back rolls, as well as skin laxicity, varies from person to person and also from one side to the other. The rolls surely have a zone of adherence inferiorly over which the tissue fold hangs and medially in the midline. Treatment modalities for back rolls depend on the above-mentioned variables and involve three general approaches:
- Suction-assisted Liposuction along alone or with other modalities of skin tightening as VASER or J-Plasma ;
- Direct surgical excision of the skin fold as an upper back lift.
- Non- surgical: Injection lipolysis in association with weight loss. The choice of treatment depends on the specific characteristic of the back roll; hence, a classification to grade the extent of back roll would help in guiding the surgeon to choose the best possible option.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female patients aged 18 to 50 years old.
- Any grad of back rolls
Exclusion Criteria:
- patients outside the selected age range
- Abnormal laboratory tests (in particular, glucose >105 g/dL, hemoglobin <12 g/dL, platelets <150,000)
- significant systemic diseases.
- previous liposuction or other back surgeries.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: patients with back rolls who undergo the back contouring surgery
|
Back rolls are assessed, and the type of surgery is determined according to grade of back rolls.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
improvement in grading of back rolls
Time Frame: six months postoperative
|
Grade I: Back rolls that appear when the arms are kept by the side and disappear when the arms are raised. Grade II: Back rolls having a single indentation (partial or complete) that reduces when the arm is raised. Grade III: Back rolls with two or more skin indentations with skin pinch of more than 2 cm. The skin fold should not be lower than the inferior tethering point. Grade IV: Back rolls secondary to massive weight loss that have multiple folds with skin pinch less than 2 cm and skin fold lower than the tethering point, or in patients who have undergone prior surgical treatment. |
six months postoperative
|
|
Compare the improvement of waist-hip ratio
Time Frame: six months postoperative
|
The waist-hip ratio (WHR) is a measurement that compares the circumference of your waist to the circumference of your hips.
It's calculated by dividing the waist measurement by the hip measurement.
|
six months postoperative
|
|
Compare the improvement of waist-chest ratio
Time Frame: six months postoperative
|
The waist-chest ratio is a measurement that compares a person's waist circumference to their chest circumference.
It's often used as an indicator of body shape and potential health risks associated with fat distribution.
|
six months postoperative
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Thomas MK, D'Silva JA, Borole AJ. Injection Lipolysis: A Systematic Review of Literature and Our Experience with a Combination of Phosphatidylcholine and Deoxycholate over a Period of 14 Years in 1269 Patients of Indian and South East Asian Origin. J Cutan Aesthet Surg. 2018 Oct-Dec;11(4):222-228. doi: 10.4103/JCAS.JCAS_117_18.
- Hunstad JP, Repta R. Bra-line back lift. Plast Reconstr Surg. 2008 Oct;122(4):1225-1228. doi: 10.1097/PRS.0b013e3181858fa4. No abstract available.
- Mowlavi A, Talle A, Berri M, Rashid W. Successful Back Contouring With Elimination of Back Rolls Using Ultrasound-Assisted Liposuction and Helium-Activated Radiofrequency. Aesthet Surg J Open Forum. 2020 Oct 26;2(4):ojaa036. doi: 10.1093/asjof/ojaa036. eCollection 2020 Dec.
- Rohrich RJ, Smith PD, Marcantonio DR, Kenkel JM. The zones of adherence: role in minimizing and preventing contour deformities in liposuction. Plast Reconstr Surg. 2001 May;107(6):1562-9. doi: 10.1097/00006534-200105000-00043.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Back rolls assessment
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Back Rolls Assesment
-
Gulf Medical UniversityCompletedImplant AssesmentEgypt
-
Mansoura UniversityActive, not recruiting
-
Mansoura UniversityActive, not recruitingCompletely Edentulous | Implant AssesmentEgypt
-
Cairo UniversityNot yet recruitingCaries Risk Assesment
-
Abant Izzet Baysal UniversityCompleted
-
Hacettepe UniversityCompletedCardiac Surgery | Drug Related Problems | Clinical Pharmacy | Risk AssesmentTurkey
-
National Institute of Cardiovascular Diseases,...RecruitingCardiovascular Morbidity | Cardiovascular Risk Assesment | Primary Prevention CVDPakistan
-
Mansoura UniversityActive, not recruitingVitamin D Deficiency | Radiography | Clinical and Radiographic Effect | Implant AssesmentEgypt
-
UfoniaUniversity College London Hospitals; University of YorkNot yet recruitingOsteoporosis | Telemedicine | Bone Health | Outpatient | Automation | AI (Artificial Intelligence) | Risk Assesment
-
Fatih Sultan Mehmet Training and Research HospitalCompletedUltrasonography | Intensive Care (ICU) | Weaning Mechanical Ventilation | Assesment of Diaphragmatic Function by Ultrasound to Predict Weaning Success in Mechanical Ventilated Intensive Care Unit Patients | Diaphragm UsgTurkey (Türkiye)
Clinical Trials on Back contouring surgery
-
Medical University of ViennaCompleted
-
University Hospital, Basel, SwitzerlandCompleted
-
Odense University HospitalMcMaster University; Catharina Ziekenhuis Eindhoven; Tampere University Hospital and other collaboratorsRecruitingWeight Loss | Excess SkinDenmark
-
Assiut UniversityCompletedBariatric Surgery CandidateEgypt
-
Royal North Shore HospitalRecruitingArtificial Intelligence | Deep Learning | Radiation Therapy | Segmentation | ContouringAustralia
-
Back and Rehabilitation Center, CopenhagenUniversity of Southern Denmark; University Hospital Bispebjerg and FrederiksbergCompletedLumbar Disc Herniation | Lumbar Spinal StenosisDenmark
-
Recros Medica, Inc.UnknownSkin LaxityUnited States
-
University of British ColumbiaCompletedObesity | Weight LossCanada
-
Academisch Medisch Centrum - Universiteit van Amsterdam...ZonMw: The Netherlands Organisation for Health Research and DevelopmentRecruiting
-
Hasselt UniversityJessa Hospital; Ziekenhuis Oost-LimburgCompleted