LipodystrophyNCT04656054
Hemoglobin Level, Coagulopathy Profile and Electrolyte Balance
An observational study of Lipodystrophy and Obesity, run by Alaa Hassan M. Elhawary at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lipodystrophy, Obesity
- What is being tested?
- liposuction
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2020to 20 Feb 2024
- How long will I take part?
- 4 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Female patient.
- Age: 25-45 years.
- BMI <40
- Large volume liposuction
- Patient asking for liposuction or suction assisted lipoectomy.
Who cannot join
- Male patient.
- Age >45 or <25 years.
- Uncontrolled chronic diseases as DM, HTN.
- Show degrees of lipodystropy at breast.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Changes in Hemoglobin Level, Coagulopathy Profile and Electrolyte Balance in Large Volume Liposuction Patients But in Different Surface Areas.
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.
- Conditions
- Lipodystrophy, Obesity
- Being tested
- liposuction
- Keywords
- Liposuction., Large volume., electrolyte imbalance.
- Medical subject headings
- Lipodystrophy, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liposuctionProcedure or surgery
liposuction procedure and observation of the hematological changes on the patients
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start1 Nov 2020
- Primary completion15 Dec 2023
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipodystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 4 Days
Sponsor and investigators
- Lead sponsor
- Alaa Hassan M. Elhawary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alaa Hassan M. Elhawary, Assiut University
- Investigators
- Assem H. Abdelhafez, professor, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656054
- Sponsor's protocol ID
- large volume liposuction
- Status last verified
- Feb 2024
- First submitted
- 5 Apr 2020
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Changes in Hemoglobin Level, Coagulopathy Profile and Electrolyte Balance in Large Volume Liposuction Patients But in Different Surface Areas.
- ClinicalTrials.gov ID
- NCT04656054
- Acronym / sponsor ID
- large volume liposuction
- Conditions
- Lipodystrophy, Obesity
- Keywords
- Liposuction., Large volume., electrolyte imbalance.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Alaa Hassan M. ElhawaryUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Days
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- Female patient.
- Age: 25-45 years.
- BMI <40
- Large volume liposuction
- Patient asking for liposuction or suction assisted lipoectomy.
Key exclusion criteria (4 listed)
- Male patient.
- Age >45 or <25 years.
- Uncontrolled chronic diseases as DM, HTN.
- Show degrees of lipodystropy at breast.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liposuctionliposuction procedure and observation of the hematological changes on the patients | Procedure or surgery | – |
Primary outcome
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.
Time frame: 1 year
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.
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.
Time frame: 1 year
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.
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.
Time frame: 1 year
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.
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.
Time frame: 1 year.
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.
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.
Time frame: 1 year.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Assem H. Abdelhafez, professor study chair
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipodystrophy and Obesity, run by Alaa Hassan M. Elhawary at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.