Hemoglobin Level, Coagulopathy Profile and Electrolyte Balance

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Brief Title

Hemoglobin Level, Coagulopathy Profile and Electrolyte Balance

Official Title

Comparing the Changes in Hemoglobin Level, Coagulopathy Profile and Electrolyte Balance in Large Volume Liposuction Patients But in Different Surface Areas.

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.
    

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 Type

Observational [Patient Registry]


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.


Condition

Lipodystrophy

Intervention

liposuction


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

20

Start Date

November 1, 2020

Completion Date

October 31, 2022

Primary Completion Date

June 30, 2022

Eligibility Criteria

        Inclusion Criteria:

          1. Female patient.

          2. Age: 25-45 years.

          3. BMI <40

          4. Large volume liposuction

          5. Patient asking for liposuction or suction assisted lipoectomy.

        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.
      

Gender

Female

Ages

25 Years - 45 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Assem H. Abdelhafez, professor, 01096778330, [email protected]

Location Countries

Egypt

Location Countries

Egypt

Administrative Informations


NCT ID

NCT04656054

Organization ID

large volume liposuction


Responsible Party

Sponsor-Investigator

Study Sponsor

Alaa Hassan M. Elhawary


Study Sponsor

Assem H. Abdelhafez, professor, Study Chair, Assiut University


Verification Date

November 2020