- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06453772
How to Predict Post-Surgical Bleeding and Hemoglobin in Liposuction?
May 30, 2025 updated by: Clotilde Fuentes-Orozco, Instituto Mexicano del Seguro Social
Effect of Using a Mathematical Model Based on pre-and Post-surgical Hemoglobin Differences to Determine the Volume to Aspirate in Primary Body Liposuction.
To evaluate the effect of using a mathematical model developed through pre- and post-surgical hemoglobins to predict the volume to aspirate in patients undergoing primary body liposuction.
Study Overview
Detailed Description
Postoperative anemia is a significant risk associated with liposuction, yet the scientific literature lacks detailed data on blood loss relative to the volume of fat removed.
To address this, the investigators aimed to develop a mathematical formula predicting the decrease in postoperative hemoglobin (Hb post) based on preoperative hemoglobin (Hb pre), Body Mass Index (BMI), and the volume of fat suctioned.
An observational, analytical, non-experimental, prospective study was conducted on liposuction patients to validate this predictive formula.
Statistical analysis using Spearman's test showed that the results were statistically significant (P < 0.05).
Study Type
Observational
Enrollment (Actual)
700
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jalisco
-
Guadalajara, Jalisco, Mexico, 44340
- Western Medical Center, Mexican Institute of Social Security
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Guadalajara, Jalisco, Mexico, 44329
- National Western Speciality Hospital, Mexican Social Security Institute
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-
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
Yes
Sampling Method
Non-Probability Sample
Study Population
Patients undergoing the first-time liposuction procedure, operated in the Plastic and Reconstructive Surgery Service
Description
Inclusion Criteria:
- Patients of indistinct gender, operated on at the Centro Médico Nacional de Occidente for primary liposuction.
- Age between 18 to 60 years old
- Liposuction technique used: Super wet or Tumescent.
- Surgical procedure on any area of the body
- Large volume liposuction (> 5 L)
- Use of regional anesthesia
Exclusion Criteria:
- Presence of any of the following comorbidities: Systemic Arterial Hypertension or Diabetes Mellitus type 2.
- Performance of 2 or more procedures
- Use of medications (NSAIDs and/or coadjuvants that modify coagulation times).
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 |
|---|---|
|
Patients undergoing liposuction
|
Primary or secondary liposuction is performed by the surgical staff.
The study analyzed variables including weight, height, BMI, preoperative hemoglobin, and aspirated volume.
Additionally, preoperative hemoglobin (Hb), hematocrit (Hto), platelets, prothrombin time (Tp), partial prothrombin time (TpT), and International Normalized Ratio (INR) were evaluated.
Hb and Hto levels were reassessed 24 hours post-surgery to monitor changes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bleeding Predicting Method
Time Frame: 12 months
|
Mathematical model based on pre-and post-surgical hemoglobins to further predict estimated bleeding
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
January 1, 2022
Primary Completion (Actual)
December 1, 2022
Study Completion (Actual)
December 1, 2022
Study Registration Dates
First Submitted
May 30, 2024
First Submitted That Met QC Criteria
June 5, 2024
First Posted (Actual)
June 12, 2024
Study Record Updates
Last Update Posted (Actual)
June 4, 2025
Last Update Submitted That Met QC Criteria
May 30, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LIPOSUCTION-24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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