- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07805941
Prospective Evaluation of Body Image, Physical, Psychological, Sexual, and Social Outcomes After Posterior Aesthetic Rib Remodeling
September 1, 2026 updated by: Research Inc
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Adults who independently elect posterior rib remodeling will be enrolled before surgery.
The study will administer a prespecified subset of licensed BODY-Q scales and will obtain standardized anthropometric and photographic measurements at baseline and at 1, 3, 6, and 12 months.
Each BODY-Q scale will be scored independently.
Mixed-effects models will estimate change in body image and other functional domains, and regression analyses will assess whether changes correspond to objective waist reduction.
Complications and major weight change will be incorporated into the interpretation of outcomes.
Study Type
Observational
Enrollment (Estimated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hugo Aguilar, MD, Plastic surgeon
- Phone Number: +57 301 6918526
- Email: havplasticacademy@gmail.com
Study Locations
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-
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Bogotá, Colombia
- Recruiting
- Clinica INO
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Contact:
- hugo Aguilar, MD, Plastic surgeon
- Phone Number: +57 3016918526
- Email: havplasticacademy@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adults who independently elect posterior aesthetic rib remodeling and agree to longitudinal anthropometric and patient-reported outcome assessment.
Description
Inclusion Criteria:
- 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.
- Written informed consent for prospective data collection.
Exclusion Criteria:
- 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.
- Inability to complete baseline BODY-Q or standardized waist measurement.
- Participation in another intervention expected to independently alter body image outcomes during follow-up.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Posterior Rib Remodeling Cohort
Participants undergo the clinically selected posterior rib remodeling procedure and complete prospective BODY-Q and anthropometric assessments.
|
Posterior 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.
Selected 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in BODY-Q Body Image Score
Time Frame: Baseline and postoperative month 12. 1 year
|
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.
|
Baseline and postoperative month 12. 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in BODY-Q Sexual Function Score
Time Frame: Baseline, postoperative month 3, postoperative month 6, and postoperative month 12. 1 year
|
Rasch-transformed 0-to-100 BODY-Q Sexual Function score; higher scores indicate better self-reported sexual function and comfort with body appearance.
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Baseline, postoperative month 3, postoperative month 6, and postoperative month 12. 1 year
|
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Change in BODY-Q Physical, Psychological, and Social Function Scores
Time Frame: Baseline, postoperative month 3, postoperative month 6, and postoperative month 12. 1 year
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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.
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Baseline, postoperative month 3, postoperative month 6, and postoperative month 12. 1 year
|
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Change in Waist Circumference
Time Frame: Baseline, postoperative month 3, postoperative month 6, and postoperative month 12. 1 year
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Waist circumference in centimeters will be measured at a fixed anatomical landmark at end-expiration, using three repeated measurements averaged at each visit.
|
Baseline, postoperative month 3, postoperative month 6, and postoperative month 12. 1 year
|
|
Association Between Waist Reduction and BODY-Q Improvement
Time Frame: Baseline and postoperative month 12. 1 year
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Correlation and adjusted regression between change in waist circumference and change in each prespecified BODY-Q domain.
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Baseline and postoperative month 12. 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hugo Aguilar, MD, plastic surgery
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Onate Valdivieso C, Onate Valdivieso D, Hoyos AE, Perez Pachon ME, Aguilar Villa H, Michels PJA, Viera A, Benavides JE, Villabona SJ, Ramirez B. Ultrasonic- and Ultrasound-assisted Improvement of Silhouette of the Torso: Bone Structure High-definition Remodeling (Part I). Plast Reconstr Surg Glob Open. 2024 Jan 10;12(1):e5513. doi: 10.1097/GOX.0000000000005513. eCollection 2024 Jan.
- Aguilar Villa H, Villabona-Florez SJ, Hoyos AE, Perez Pachon ME, Serrano-Reyes HM, Diaz Sandoval CJ. Aesthetic Rib Cage Remodeling with Osteosynthesis: Body Structural High-Definition Reshaping (Rib Osteotomy with Osteosynthesis Stabilization). Plast Reconstr Surg. 2025 Feb 1;155(2):279-288. doi: 10.1097/PRS.0000000000011512. Epub 2024 May 6.
- Manzaneda Cipriani RM, Duran Vega H, Cala Uribe L, Viaro M, Adrianzen GA, Botelho DL. Waist Remodeling without Incision, with Ultrasound-guided Monocortical Fracture. Plast Reconstr Surg Glob Open. 2023 Dec 19;11(12):e5499. doi: 10.1097/GOX.0000000000005499. eCollection 2023 Dec.
- Aguilar HA, Hoyos AE, Ramirez B, Kazbek K, Viacheslav N, Villabona SJ, Serrano HM, Perez Pachon ME, Valdivieso DO, Valdivieso CO, Kazbek G, Proto R, Verdugo JP, Varela A. Global Survey on Rib Remodeling Techniques: Assessing Complications and Safety in Waistline Contouring. Plast Reconstr Surg Glob Open. 2026 Apr 13;14(4):e7609. doi: 10.1097/GOX.0000000000007609. eCollection 2026 Apr.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2024
Primary Completion (Actual)
May 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
September 1, 2026
First Submitted That Met QC Criteria
September 1, 2026
First Posted (Actual)
September 8, 2026
Study Record Updates
Last Update Posted (Actual)
September 8, 2026
Last Update Submitted That Met QC Criteria
September 1, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 014 (Nahrain Medical Research Collective (NMRC))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
NOT CONTEMPLED IN THE PATIENT INFORMED CONSENT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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