Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2026-01-02 @ 5:24 AM
Study NCT ID:
NCT07051759
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-04
First Post:
2025-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Back Rolls Assessment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '* Based on determining the main outcome variable, the estimated minimum required sample size is 30 cases.\n* Sample size was calculated using G\\*power software 3.1.9.7., based on the following assumptions:\n* Main outcome is difference in waist chest ratio in patients before and six months after surgery.\n* Based on clinical experience and after reviewing literatures there is a medium difference.\n* Main statistical test is one tailed paired t test to detect the difference between two means.\n* Effect size =0.5\n* Alpha=0.05\n* Power=0.80'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-10-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-03', 'studyFirstSubmitDate': '2025-06-22', 'studyFirstSubmitQcDate': '2025-07-03', 'lastUpdatePostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'improvement in grading of back rolls', 'timeFrame': 'six months postoperative', 'description': 'Grade I: Back rolls that appear when the arms are kept by the side and disappear when the arms are raised.\n\nGrade II: Back rolls having a single indentation (partial or complete) that reduces when the arm is raised.\n\nGrade 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.\n\nGrade 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.'}, {'measure': 'Compare the improvement of waist-hip ratio', 'timeFrame': 'six months postoperative', 'description': "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."}, {'measure': 'Compare the improvement of waist-chest ratio', 'timeFrame': 'six months postoperative', 'description': "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."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Back rolls management', 'Back rolls assessment'], 'conditions': ['Back Rolls Assesment', 'Back Rolls Management']}, 'referencesModule': {'references': [{'pmid': '30886477', 'type': 'BACKGROUND', 'citation': "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': '18827659', 'type': 'RESULT', 'citation': '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': '33791662', 'type': 'RESULT', 'citation': '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': '11335837', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '"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".\n\nThe 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:\n\n1. Suction-assisted Liposuction along alone or with other modalities of skin tightening as VASER or J-Plasma ;\n2. Direct surgical excision of the skin fold as an upper back lift.\n3. 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients aged 18 to 50 years old.\n* Any grad of back rolls\n\nExclusion Criteria:\n\n* patients outside the selected age range\n* Abnormal laboratory tests (in particular, glucose \\>105 g/dL, hemoglobin \\<12 g/dL, platelets \\<150,000)\n* significant systemic diseases.\n* previous liposuction or other back surgeries.'}, 'identificationModule': {'nctId': 'NCT07051759', 'acronym': 'Back rolls', 'briefTitle': 'Back Rolls Assessment', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Assessment of Back Rolls and Algorithm of Management', 'orgStudyIdInfo': {'id': 'Back rolls assessment'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients with back rolls who undergo the back contouring surgery', 'interventionNames': ['Procedure: Back contouring surgery']}], 'interventions': [{'name': 'Back contouring surgery', 'type': 'PROCEDURE', 'otherNames': ['Back liposuction', 'Bra line back lift'], 'description': 'Back rolls are assessed, and the type of surgery is determined according to grade of back rolls.', 'armGroupLabels': ['patients with back rolls who undergo the back contouring surgery']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The majority of patients involved in this type of research are unwilling to disclose personal details beyond the scope of the study itself.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hager Montaser Sayed Bedeer', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hager Montaser Sayed Bedeer', 'investigatorAffiliation': 'Assiut University'}}}}