How to Predict Post-Surgical Bleeding and Hemoglobin in Liposuction?

Surgery Clinical Trial

Official title:

Effect of Using a Mathematical Model Based on pre-and Post-surgical Hemoglobin Differences to Determine the Volume to Aspirate in Primary Body Liposuction.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06453772
• Other study ID #: LIPOSUCTION-24
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: June 2024
• Source: Instituto Mexicano del Seguro Social
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Bleeding
• Hemorrhage
• Surgery

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Mexico	National Western Speciality Hospital, Mexican Social Security Institute	Guadalajara	Jalisco
Mexico	Western Medical Center, Mexican Institute of Social Security	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Mexicano del Seguro Social

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding Predicting Method	Mathematical model based on pre-and post-surgical hemoglobins to further predict estimated bleeding	12 months