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

Not Applicable

• Conditions: Thigh Lipodystrophy
• Interventions: Procedure: thigh lift

• Registration Number: NCT03283475
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study Start: 2017-05-14
• Status Verified: 2017-09
• Study First Submitted: 2017-09-13
• Study First Submitted QC: 2017-09-13
• Last Update Submitted: 2017-09-13
• Study First Posted: 2017-09-14
• Last Update Posted: 2017-09-14
• Primary Completion: 2018-10-22
• Study Completion: 2019-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
patient group	thigh lift	- 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.

Primary Outcome Measures

Name	Time	Method
regarding patient satisfaction and achievement of symmetry.	3 months	questionnaire will be performed for the patient group to estimate degree of patient satisfaction with assessment of postoperative symmetry

Secondary Outcome Measures

Name	Time	Method
complication rates of different surgical techniques	1 week and 3 months	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.

Trial Locations

Locations (1)

Assiut university; 🇪🇬 Assiut, Egypt