ClinicalTrials.gg
CompletedNCT04656054Updated Oct 1, 2025

Hemoglobin Level, Coagulopathy Profile and Electrolyte Balance

An observational study in Lipodystrophy and Obesity, sponsored by Alaa Hassan M. Elhawary. Completed at 1 site in Egypt. Open to female participants aged 25 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-01.

Sponsored by Alaa Hassan M. Elhawary · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
25 Years to 45 Years
Sex
Female
01

Study 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.

Read the detailed description

Liposuction is fat- removing aesthetic surgery procedure that aims to body contouring. Liposuction is the most frequently performed aesthetic surgery procedure in Western Countries. This technique has had rapid development since the 1970s, when it was experimented for the first time by A. and G. Fischer. It is currently widely used in clinical practice for many different situations in aesthetic, reconstructive and functional fields.

At 1970s, fat removal was carried out with a blunt curette. This technique was modified in 1977 by a French surgeon, Yves Gerard Illouz, who added hyaluronidase and saline to emulsify the fatty tissue, and hence facilitate aspiration with the use of liposuction cannula. This was termed the 'wet technique' and was introduced to reduce blood loss during the procedure.

The current options for wetting solutions are dry, wet, superwet, and tumescent. The dry technique employs no wetting solution and has few indications in liposuction. The wet technique involves instillation of 200 to 300 mL of solution per area to be treated, regardless of the amount aspirated. The superwet technique employs an infiltration of 1 mL per estimated mL of expected aspirate, and this is the technique practiced at our institution. Tumescent infiltration, popularized by Klein, involves infiltration of wetting solution that creates significant tissue turgor and results in infiltration of 3 to 4 mL of wetting solution per mL aspirated. Regardless of technique, the infiltrate should be allowed to take effect for seven minutes prior to suctioning.

Most studies consider the most important parameter, to determine the safety of liposuction, is the amount (volume) of aspirated fluid. A review of the scientific literature shows that there are no scientific data available to support a specific volume maximum at which point liposuction is no longer safe, although the risk of complications is unavoidably higher as the volume of aspirate and the number of anatomic sites treated increase.

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.

In large volume liposuction, there is potential for large fluid shifts secondary to the volume of tissue removed, with a risk of developing pulmonary edema, high-volume liposuction is significantly more prone to complications than the original form of liposuction.

There is a long history of debate over the safe volume of fat tissue that can be removed by liposuction. Current ASPS guidelines define 5,000 milliliters (five liters) as "large-volume liposuction" potentially associated with a higher risk of complications. But the guidelines acknowledge there is no scientific data to support an absolute cutoff point. Patients with complications had larger liposuction volumes-average 3.4 liters-and higher BMIs. Patients undergoing "large-volume" liposuction of more than five liters had a higher overall complication rate: 3.7 versus 1.1 percent.

On the other hand, 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.

Only few studies have mentioned the effect of surface area on liposuction and none of those studies have been published at certified impacted magazine.

In this study considers the amount of liposuction is a constant factor (Large volume liposuction) and the surface area is the variant to detect the changes in hemogram, coagulation profile and electrolyte imbalance that may lead to possible complication.

02

Conditions studied

  • Lipodystrophy
  • Obesity

Keywords

  • Liposuction.
  • Large volume.
  • electrolyte imbalance.
03

In context

Lipodystrophy

139 studies on the registry are indexed under Lipodystrophy; 10 are open to participants now.

This study's enrollment of 20 is below the median of 104 across 34 observational studies indexed under Lipodystrophy.

Browse Lipodystrophy studies →

Lead sponsor

This is the only study on the registry with Alaa Hassan M. Elhawary as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Female patient.
  2. Age: 25-45 years.
  3. \<40
  4. Large volume liposuction
  5. Patient asking for liposuction or suction assisted lipoectomy.

Exclusion criteria

Exclusion Criteria:

  1. Male patient.
  2. Age >45 or \<25 years.
  3. Uncontrolled chronic diseases as DM, HTN.
  4. Show degrees of lipodystropy at breast.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Target follow-up
4 Days
Patient registry
Yes

Interventions

  • Procedureliposuction

    liposuction procedure and observation of the hematological changes on the patients

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

  2. 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.

    Time frame: 1 year

  3. 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.

    Time frame: 1 year

  4. 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.

    Time frame: 1 year.

  5. 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.

    Time frame: 1 year.

07

Study locations

1 site
  • Assuit University
    Asyut, Assuit 71515, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2020 to primary completion in Dec 2023, 37 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 5, 2020
First posted
Dec 7, 2020
StartActual
Nov 1, 2020
Primary completionActual
Dec 15, 2023
CompletionActual
Feb 20, 2024
Last update
Oct 1, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04656054
Lead sponsor
Alaa Hassan M. Elhawary
Responsible party
Alaa Hassan M. Elhawary (Residant doctor at plastic surgery department, Assiut University hospital., Assiut University) — Sponsor-investigator
First posted
Dec 7, 2020
Start date
Nov 1, 2020
Primary completion
Dec 15, 2023
Completion
Feb 20, 2024
Last update
Oct 1, 2025

Study contacts

Assem H. Abdelhafez, professor
study chair · Assiut University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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