Prospective Evaluation of Body Image, Physical, Psychological, Sexual, and Social Outcomes After Posterior Aesthetic Rib Remodeling
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorResearch Inc
About this trial
This prospective observational cohort will evaluate patient-reported and anthropometric outcomes after posterior aesthetic rib remodeling. Selected BODY-Q scales will measure body image, physical, psychological, sexual, and social function before surgery and through 12 months. Standardized waist and hip measurements will be collected at the same visits. The primary outcome is change in BODY-Q Body Image score at one year, and analyses will assess whether patient-reported improvement is associated with sustained waist reduction.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 to 65 years.
Scheduled for posterior aesthetic rib remodeling after an independent clinical decision.
Ability to complete validated Spanish-language BODY-Q scales and follow-up visits.
Stable body weight for at least 3 months before surgery.
Disqualifiers
Prior posterior rib remodeling or rib resection.
Planned pregnancy during the 12-month follow-up.
Major weight-loss intervention planned during follow-up.
Psychiatric or cognitive condition preventing reliable completion of patient-reported measures.
Trial population
Adults who independently elect posterior aesthetic rib remodeling and agree to longitudinal anthropometric and patient-reported outcome assessment.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Posterior Aesthetic Rib Remodeling
Procedure/SurgeryPosterior rib remodeling is performed according to the treating surgeon's standardized RIBOSS technique and clinical indications. The research protocol does not assign surgery; it observes outcomes after the independent treatment decision. Linked arm/group(s): Posterior Rib Remodeling Cohort.
BODY-Q Assessment
Other interventionSelected licensed BODY-Q scales will be administered using the authorized Spanish translation and Rasch transformation. Proposed scales are Body Image, Physical Function, Psychological Function, Sexual Function, Social Function, and Body or Abdomen appearance satisfaction. Linked arm/group(s): Posterior Rib Remodeling Cohort.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Posterior Rib Remodeling Cohort2 interventions
Trial outcomes
Primary outcomes
1
Change in BODY-Q Body Image Score
Rasch-transformed 0-to-100 BODY-Q Body Image score; higher scores indicate a more positive body image. Change is the postoperative month-12 score minus baseline.
Time frame
Baseline and postoperative month 12. 1 yearSecondary outcomes
1
Change in BODY-Q Sexual Function Score
Rasch-transformed 0-to-100 BODY-Q Sexual Function score; higher scores indicate better self-reported sexual function and comfort with body appearance.
Time frame
Baseline, postoperative month 3, postoperative month 6, and postoperative month 12. 1 year2
Change in BODY-Q Physical, Psychological, and Social Function Scores
Each selected BODY-Q scale is independently transformed to 0 to 100, with higher scores indicating better function. Scores will not be combined into an unvalidated total.
Time frame
Baseline, postoperative month 3, postoperative month 6, and postoperative month 12. 1 year3
Change in Waist Circumference
Waist circumference in centimeters will be measured at a fixed anatomical landmark at end-expiration, using three repeated measurements averaged at each visit.
Time frame
Baseline, postoperative month 3, postoperative month 6, and postoperative month 12. 1 year4
Association Between Waist Reduction and BODY-Q Improvement
Correlation and adjusted regression between change in waist circumference and change in each prespecified BODY-Q domain.
Time frame
Baseline and postoperative month 12. 1 yearSponsors and contacts
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Source ClinicalTrials.gov