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Different Surgical Modalities for Thigh Lipodystrophy Including Liposuction,Thigh Lift and Liposuction Assisted Thigh Lift (thigh lift)

Primary Purpose

Thigh Lipodystrophy

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
thigh lift
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thigh Lipodystrophy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Individuals between18 and 35 years for control group and more than 18 years for patient group .
  2. Patients with BMI between 19 and 25 for control group and less than 35 for patient group.

Exclusion Criteria:

  1. Individuals less than 18 years.
  2. Patients undergoing bariatric surgery within a period of less than one year.
  3. Patients with BMI more than 35.
  4. Patients with systemic illness as cancer or mental disorders & hepatic patients (generally debilitating diseases) or any contraindication for anesthesia.

Sites / Locations

  • Assiut university

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

control group

patient group

Arm Description

- Control group will include 60 adult individuals between 18 and 35 years old who have body mass index (BMI) between 19 and 25, not complaining of any thigh contour deformities or skin redundancy with no history of body weight fluctuations. This group will be divided into two subgroups, 30 males and 30 females. The following measurements will be recorded :- Weight, height, thigh length, hip circumference, maximum buttocks circumference, upper thigh, middle thigh and lower thigh circumferences.

- Patient group will include 30 patients suffering from thigh lipodystrophy and contour deformities who will undergo surgical intervention after their assessment. After assessment, one of the following techniques will be selected:- Liposuction only. thigh lift. Liposuction assisted thigh lift.

Outcomes

Primary Outcome Measures

regarding patient satisfaction and achievement of symmetry.
questionnaire will be performed for the patient group to estimate degree of patient satisfaction with assessment of postoperative symmetry

Secondary Outcome Measures

complication rates of different surgical techniques
Early complications will be assessed within one week after surgery including hematoma, seroma, surgical site infection and wound dehiscence. Late complications will be assessed at 3 months follow up including asymmetry, conspicuous scar and lymphedema.

Full Information

First Posted
September 13, 2017
Last Updated
September 13, 2017
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03283475
Brief Title
Different Surgical Modalities for Thigh Lipodystrophy Including Liposuction,Thigh Lift and Liposuction Assisted Thigh Lift
Acronym
thigh lift
Official Title
Surgical Management of Thigh Lipodystrophy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 14, 2017 (Actual)
Primary Completion Date
October 22, 2018 (Anticipated)
Study Completion Date
April 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The sample will be divided into two groups:- - Control group which will include 60 adult individuals between 18 and 35 years old who have BMI between 19 and 25, not complaining of any thigh contour deformities or skin redundancy with no history of body weight fluctuations. This group will be divided into two subgroups, 30 males and 30 females. The following measurements will be recorded :- Weight, height, thigh length, hip circumference, maximum buttocks circumference, upper thigh, middle thigh and lower thigh circumferences. - Patient group which will include 40 patients suffering from thigh lipodystrophy and contour deformities who will undergo surgical intervention after their assessment. After assessment, one of the following techniques will be selected:- Liposuction only. thigh lift. Liposuction assisted thigh lift.
Detailed Description
Preoperative assessment:- Patients will be assessed regarding skin redundancy, history of weight loss and site of lipodystrophy whether deformity is proximal, distal or diffuse. The same measurements mentioned above will be recorded for the patient group before surgery. Preoperative photographs in anteroposterior, lateral and oblique positions will be taken. Informed consent will be signed by the patient before surgery illustrating possible risks and complications of the surgery. Postoperative assessment:- The outcomes will be evaluated 3 months after surgery regarding patient satisfaction and achievement of symmetry. Early complications will be assessed within one week after surgery including hematoma, seroma, surgical site infection and wound dehiscence. Late complications will be assessed at 3 months follow up including asymmetry, conspicuous scar and lymphedema. Postoperative measurements and photographs will be recorded and compared with preoperative ones.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thigh Lipodystrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The sample will be divided into two groups:- - Control group which will include 60 adult individuals between 18 and 35 years old who have BMI between 19 and 25, not complaining of any thigh contour deformities or skin redundancy with no history of body weight fluctuations. This group will be divided into two subgroups, 30 males and 30 females. The following measurements will be recorded :- Weight, height, thigh length, hip circumference, maximum buttocks circumference, upper thigh, middle thigh and lower thigh circumferences. - Patient group which will include 40 patients suffering from thigh lipodystrophy and contour deformities who will undergo surgical intervention after their assessment. After assessment, one of the following techniques will be selected:- Liposuction only. thigh lift. Liposuction assisted thigh lift.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
- Control group will include 60 adult individuals between 18 and 35 years old who have body mass index (BMI) between 19 and 25, not complaining of any thigh contour deformities or skin redundancy with no history of body weight fluctuations. This group will be divided into two subgroups, 30 males and 30 females. The following measurements will be recorded :- Weight, height, thigh length, hip circumference, maximum buttocks circumference, upper thigh, middle thigh and lower thigh circumferences.
Arm Title
patient group
Arm Type
Active Comparator
Arm Description
- Patient group will include 30 patients suffering from thigh lipodystrophy and contour deformities who will undergo surgical intervention after their assessment. After assessment, one of the following techniques will be selected:- Liposuction only. thigh lift. Liposuction assisted thigh lift.
Intervention Type
Procedure
Intervention Name(s)
thigh lift
Other Intervention Name(s)
thigh liposuction, liposuction assisted thigh lift
Intervention Description
liposuction-assisted medial avulsion thighplasty enables technically refined contouring of the thigh and the possible preservation of the local microvasculature, which results in reduced complication rates
Primary Outcome Measure Information:
Title
regarding patient satisfaction and achievement of symmetry.
Description
questionnaire will be performed for the patient group to estimate degree of patient satisfaction with assessment of postoperative symmetry
Time Frame
3 months
Secondary Outcome Measure Information:
Title
complication rates of different surgical techniques
Description
Early complications will be assessed within one week after surgery including hematoma, seroma, surgical site infection and wound dehiscence. Late complications will be assessed at 3 months follow up including asymmetry, conspicuous scar and lymphedema.
Time Frame
1 week and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Individuals between18 and 35 years for control group and more than 18 years for patient group . Patients with BMI between 19 and 25 for control group and less than 35 for patient group. Exclusion Criteria: Individuals less than 18 years. Patients undergoing bariatric surgery within a period of less than one year. Patients with BMI more than 35. Patients with systemic illness as cancer or mental disorders & hepatic patients (generally debilitating diseases) or any contraindication for anesthesia.
Facility Information:
Facility Name
Assiut university
City
Assiut
ZIP/Postal Code
71621
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27443046
Citation
Cabbabe SW. Plastic Surgery after Massive Weight Loss. Mo Med. 2016 May-Jun;113(3):202-6.
Results Reference
background
PubMed Identifier
27219231
Citation
Schmidt M, Pollhammer MS, Januszyk M, Duscher D, Huemer GM. Concomitant Liposuction Reduces Complications of Vertical Medial Thigh Lift in Massive Weight Loss Patients. Plast Reconstr Surg. 2016 Jun;137(6):1748-1757. doi: 10.1097/PRS.0000000000002194.
Results Reference
result

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Different Surgical Modalities for Thigh Lipodystrophy Including Liposuction,Thigh Lift and Liposuction Assisted Thigh Lift

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