Back Rolls Assessment

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-20

Study Completion Date

2028-10-20

Brief Summary

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"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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Detailed Description

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Conditions

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Back Rolls Assesment Back Rolls Management

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

* 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

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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patients with back rolls who undergo the back contouring surgery

Group Type EXPERIMENTAL

Back contouring surgery

Intervention Type PROCEDURE

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

Interventions

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Back contouring surgery

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

Intervention Type PROCEDURE

Other Intervention Names

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Back liposuction Bra line back lift

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No