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NCT Number: NCT07051759

Back Rolls Assessment

"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.

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Key information

Conditions

Back Rolls Assesment Back Rolls Management

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Back contouring surgery

Procedure

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

Other names: Back liposuction, Bra line back lift

Primary outcomes

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.
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.
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.

Sponsors and collaborators

Lead sponsor

Hager Montaser Sayed Bedeer

Other

Registry information

Official study title

Assessment of Back Rolls and Algorithm of Management

Acronym: Back rolls

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2028
First posted: Jul 4, 2025
Registry last updated: Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.