Clinical trial NCT03283475: Different Surgical Modalities for Thigh Lipodystrophy Including Liposuction,Thigh Lift and Liposuction Assisted Thigh Lift
Official title: Surgical Management of Thigh Lipodystrophy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thigh Lipodystrophy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-09-14
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: regarding patient satisfaction and achievement of symmetry.
timeFrame: 3 months
Secondary outcomes:
measure: complication rates of different surgical techniques
timeFrame: 1 week and 3 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
citation: Cabbabe SW. Plastic Surgery after Massive Weight Loss. Mo Med. 2016 May-Jun;113(3):202-6.
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.