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NCT Number: NCT07805941

Prospective Evaluation of Body Image, Physical, Psychological, Sexual, and Social Outcomes After Posterior Aesthetic Rib Remodeling

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Posterior Aesthetic Rib Remodeling

Procedure

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 Assessment

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

    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.

  3. Change in Waist Circumference

    Time frame: Baseline, postoperative month 3, postoperative month 6, and postoperative month 12. 1 year

    Waist circumference in centimeters will be measured at a fixed anatomical landmark at end-expiration, using three repeated measurements averaged at each visit.

  4. Association Between Waist Reduction and BODY-Q Improvement

    Time frame: Baseline and postoperative month 12. 1 year

    Correlation and adjusted regression between change in waist circumference and change in each prespecified BODY-Q domain.

Study contacts

Contact information is provided by the study sponsor or research team.

Hugo Aguilar, MD, Plastic surgeon

CONTACT

[email protected]

+57 301 6918526

Sponsors and collaborators

Lead sponsor

Research Inc

Industry

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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