NCT06453772

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 12, 2024

Completed
Last Updated

June 4, 2025

Status Verified

May 1, 2025

Enrollment Period

11 months

First QC Date

May 30, 2024

Last Update Submit

May 30, 2025

Conditions

Keywords

bleedingabdominoplastyLiposuctionHemoglobin

Outcome Measures

Primary Outcomes (1)

  • Bleeding Predicting Method

    Mathematical model based on pre-and post-surgical hemoglobins to further predict estimated bleeding

    12 months

Study Arms (1)

Patients undergoing liposuction

Procedure: Liposuction

Interventions

LiposuctionPROCEDURE

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.

Patients undergoing liposuction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing the first-time liposuction procedure, operated in the Plastic and Reconstructive Surgery Service

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Western Speciality Hospital, Mexican Social Security Institute

Guadalajara, Jalisco, 44329, Mexico

Location

Western Medical Center, Mexican Institute of Social Security

Guadalajara, Jalisco, 44340, Mexico

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Lipectomy

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cosmetic TechniquesTherapeuticsBariatric SurgeryBariatricsObesity ManagementSurgical Procedures, OperativePlastic Surgery Procedures

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 30, 2024

First Posted

June 12, 2024

Study Start

January 1, 2022

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

June 4, 2025

Record last verified: 2025-05

Locations