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Not yet recruiting NCT07051759

Back Rolls Assessment

No phase Interventional Back Rolls Assesment Back Rolls Management

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Back contouring surgery.
Who it may be relevant to
Registry conditions: Back Rolls Assesment, Back Rolls Management. Basic parameters: 18 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Assessment of Back Rolls and Algorithm of Management

Overview

"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

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

Primary outcome measures

  • improvement in grading of back rolls [Time frame: six months postoperative]
  • Compare the improvement of waist-hip ratio [Time frame: six months postoperative]
  • Compare the improvement of waist-chest ratio [Time frame: six months postoperative]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 30886477
  • 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. PMID 18827659
  • 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. PMID 33791662
  • 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. PMID 11335837

Identifiers

NCT: NCT07051759 · Back rolls assessment

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗