Hemoglobin Level, Coagulopathy Profile and Electrolyte Balance

NCT04656054 | Completed

• 1 other identifier: large volume liposuction
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

What is Impact of Amount Versus Surface Area of Liposuction on Haematological Parameters, Coagulopathy Profile and Electrolyte Balance? Liposuction involves the creation of extensive subsurface trauma, comparable in many respects to the massive injury of an internal burn. Liposuction commences with cannula aspiration of several liters of fluid-engorged adipose tissue, during which small feeder vessels are inevitably torn. Operating on multiple areas increases the area of injury regardless of whether just small amounts of fat are removed. Because many of the complications associated with large volume liposuction are related to fluid shifts and fluid balance, classifying the procedure based on the total volume removed from the patient, including fat, wetting solution, and blood, makes more sense to evaluate the damage made by the procedure. Safety and aesthetic issues define large-volume liposuction as having a 5,000-ml aspirate, mega-volume liposuction as having an 8,000-ml aspirate, and giganto-volume liposuction as having an aspirate of 12,000 ml or more.

Conditions

Lipodystrophy; Obesity

Keywords

Liposuction.; Large volume.; electrolyte imbalance.

Outcome Measures

Primary Outcomes (5)

• Comparing the blood hemoglobin level pre, intra and post operative between two groups of patients, both have done large volume liposuction, with different surface areas liposuctioned.

  To compare the impact of large volume liposuction (5 to 8 liters) from different body surface areas on the patient's hemoglobin level preoperatively, intraoperative and postoperatively. The surface area will be calculated according to Lund and Browder chart by percentage (the most accurate and widely used chart to calculate total body surface area affected by a burn injury) The volume is measured by Liters. Hemoglobin level is measured by g/dl.

  1 year

• Comparing the coagulation profile (mainly prothrombin concentration and INR) pre, intra and post operative between two groups of patients, both have done large volume liposuction, with different surface areas liposuctioned.

  To compare the impact of large volume liposuction (5 to 8 liters) from different body surface areas on the patient's Coagulopathy Profile (prothrombin concentration, INR) preoperatively, intraoperative and postoperatively. The surface area will be calculated according to Lund and Browder chart by percentage (the most accurate and widely used chart to calculate total body surface area affected by a burn injury) The volume is measured by Liters. The coagulation profile includes mainly prothromin concentration( measured by percentage) and INR.

  1 year

• Comparing potassium serum ions level pre, intra and post operative between two groups of patients, both have done large volume liposuction, with different surface areas liposuctioned.

  To compare the impact of large volume liposuction (5 to 8 liters) from different body surface areas on the patient's electrolyte balance preoperatively, intraoperative and postoperatively. The surface area will be calculated according to Lund and Browder chart by percentage (the most accurate and widely used chart to calculate total body surface area affected by a burn injury) The volume is measured by Liters. The electrolyte, that are included in the study, is potassium ions measured by mmol/L.

  1 year

• Comparing the blood hematocrit level pre, intra and post operative between two groups of patients, both have done large volume liposuction, with different surface areas liposuctioned.

  To compare the impact of large volume liposuction (5 to 8 liters) from different body surface areas on the patient's hemoglobin level preoperatively, intraoperative and postoperatively. The surface area will be calculated according to Lund and Browder chart by percentage (the most accurate and widely used chart to calculate total body surface area affected by a burn injury) The volume is measured by Liters. Hematocrit level is measured by percentage.

  1 year.

• Comparing the sodium serum ions level pre, intra and post operative between two groups of patients, both have done large volume liposuction, with different surface areas liposuctioned.

  To compare the impact of large volume liposuction (5 to 8 liters) from different body surface areas on the patient's electrolyte balance preoperatively, intraoperative and postoperatively. The surface area will be calculated according to Lund and Browder chart by percentage (the most accurate and widely used chart to calculate total body surface area affected by a burn injury) The volume is measured by Liters. The electrolyte, that are included in the study, is sodium ions measured by mmol/L.

  1 year.

Interventions

liposuction PROCEDURE

liposuction procedure and observation of the hematological changes on the patients

Eligibility Criteria

• Age: 25 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

To assess the impact of amount, up to 8 litres, versus surface area of liposuction on haematological parameters, coagulopathy profile and electrolyte balance.

You may qualify if:

• Female patient.
• Age: 25-45 years.
• BMI \<40
• Large volume liposuction
• Patient asking for liposuction or suction assisted lipoectomy.

You may not qualify if:

• Male patient.
• Age \>45 or \<25 years.
• Uncontrolled chronic diseases as DM, HTN.
• Show degrees of lipodystropy at breast.

Sponsors & Collaborators

• Alaa Hassan M. Elhawary: lead

Study Sites (1)

Assuit University

Asyut, Assuit, 71515, Egypt

Location

MeSH Terms

Conditions

Lipodystrophy; Obesity

Interventions

Lipectomy

Condition Hierarchy (Ancestors)

Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Bariatric Surgery; Bariatrics; Obesity Management; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Assem H. Abdelhafez, professor

  Assiut University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Residant doctor at plastic surgery department, Assiut University hospital.

Study Record Dates

• First Submitted: April 5, 2020
• First Posted: December 7, 2020
• Study Start: November 1, 2020
• Primary Completion: December 15, 2023
• Study Completion: February 20, 2024
• Last Updated: October 1, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)