Body ImageNCT07805941
Prospective Evaluation of Body Image, Physical, Psychological, Sexual, and Social Outcomes After Posterior Aesthetic Rib Remodeling
An observational study of Body Image and Aesthetic Surgery Outcome, run by Research Inc at 1 site in Colombia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Body Image, Aesthetic Surgery Outcome
- What is being tested?
- Posterior Aesthetic Rib Remodeling and BODY-Q Assessment
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteColombia
- Study dates
- 1 Feb 2024to 1 Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults who independently elect posterior aesthetic rib remodeling and agree to longitudinal anthropometric and patient-reported outcome assessment.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site, 1 recruiting
- Recruiting
Clinica INO
Bogotá
hugo Aguilar, MD, Plastic surgeon, +57 3016918526, havplasticacademy@gmail.com
About this study
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.
Read the 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.
- Conditions
- Body Image, Aesthetic Surgery Outcome
- Being tested
- Posterior Aesthetic Rib Remodeling, BODY-Q Assessment
- Keywords
- Rib Remodeling, RIBOSS, BODY-Q, Body Image, Sexual Function, Physical Function, Patient-Reported Outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior Aesthetic Rib RemodelingProcedure or surgery
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.
BODY-Q AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Posterior Rib Remodeling Cohort | Participants undergo the clinically selected posterior rib remodeling procedure and complete prospective BODY-Q and anthropometric assessments. Receives: Procedure: Posterior Aesthetic Rib Remodeling; Other: BODY-Q Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and postoperative month 12. 1 year
Secondary outcomes (4)
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.
Measured: Baseline, postoperative month 3, postoperative month 6, and postoperative month 12. 1 year
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.
Measured: Baseline, postoperative month 3, postoperative month 6, and postoperative month 12. 1 year
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.
Measured: Baseline, postoperative month 3, postoperative month 6, and postoperative month 12. 1 year
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.
Measured: Baseline and postoperative month 12. 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start1 Feb 2024
- Primary completion1 May 2026
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Body ImageStudies of the same condition, open and under way.
- More trials run by Research IncThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Research Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hugo Aguilar, MD, plastic surgery, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805941
- Sponsor's protocol ID
- 014
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: NOT CONTEMPLED IN THE PATIENT INFORMED CONSENT
Publications
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.
PubMed 38115833Onate 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.
PubMed 38204869Aguilar 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.
PubMed 41983160Aguilar 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.
PubMed 38710099
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Body Image, Physical, Psychological, Sexual, and Social Outcomes After Posterior Aesthetic Rib Remodeling
- ClinicalTrials.gov ID
- NCT07805941
- Acronym / sponsor ID
- 014
- Conditions
- Body Image, Aesthetic Surgery Outcome
- Keywords
- Rib Remodeling, RIBOSS, BODY-Q, Body Image, Sexual Function, Physical Function, Patient-Reported Outcomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Research IncIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Posterior Rib Remodeling Cohort | – | Procedure: Posterior Aesthetic Rib Remodeling, Other: BODY-Q AssessmentParticipants undergo the clinically selected posterior rib remodeling procedure and complete prospective BODY-Q and anthropometric assessments. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults who independently elect posterior aesthetic rib remodeling and agree to longitudinal anthropometric and patient-reported outcome assessment.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posterior Aesthetic Rib RemodelingPosterior 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. | Procedure or surgery | Posterior Rib Remodeling Cohort |
| BODY-Q AssessmentSelected 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. | Other | Posterior Rib Remodeling Cohort |
Primary outcome
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.
4 secondary outcomes
Change in BODY-Q Sexual Function Score
Time frame: Baseline, postoperative month 3, postoperative month 6, and postoperative month 12. 1 year
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
Change in Waist Circumference
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Background: PubMed 38115833Manzaneda 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.
- Background: PubMed 38204869Onate 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.
- Background: PubMed 41983160Aguilar 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.
- Background: PubMed 38710099Aguilar 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.
- Individual participant dataSharing planned: No. NOT CONTEMPLED IN THE PATIENT INFORMED CONSENT
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hugo Aguilar, MD, plastic surgery principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Body Image and Aesthetic Surgery Outcome, run by Research Inc at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hugo Aguilar, MD, Plastic surgeon (+57 301 6918526, havplasticacademy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BODY-Q Body Image Score (time frame: Baseline and postoperative month 12. 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07805941, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.