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Back Rolls Assessment

Assessment of Back Rolls and Algorithm of Management

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07051759
Acronym
Back rolls
Enrollment
30
Registered
2025-07-04
Start date
2025-07-20
Completion date
2028-10-20
Last updated
2025-07-04

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

Conditions

Back Rolls Assesment, Back Rolls Management

Keywords

Back rolls management, Back rolls assessment

Brief summary

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: 1. Suction-assisted Liposuction along alone or with other modalities of skin tightening as VASER or J-Plasma ; 2. Direct surgical excision of the skin fold as an upper back lift. 3. 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.

Interventions

PROCEDUREBack contouring surgery

Back rolls are assessed, and the type of surgery is determined according to grade of back rolls.

Sponsors

Hager Montaser Sayed Bedeer
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

* Based on determining the main outcome variable, the estimated minimum required sample size is 30 cases. * Sample size was calculated using G\*power software 3.1.9.7., based on the following assumptions: * Main outcome is difference in waist chest ratio in patients before and six months after surgery. * Based on clinical experience and after reviewing literatures there is a medium difference. * Main statistical test is one tailed paired t test to detect the difference between two means. * Effect size =0.5 * Alpha=0.05 * Power=0.80

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
improvement in grading of back rollssix months postoperativeGrade 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.
Compare the improvement of waist-hip ratiosix months postoperativeThe 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.
Compare the improvement of waist-chest ratiosix months postoperativeThe 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.

Outcome results

None listed

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