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

NCT ID: NCT03283475

Last Updated: 2017-09-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-14
• Study Completion Date: 2019-04-01

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.

Conditions

Thigh Lipodystrophy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

control group

• 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

patient group

• 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.

Group Type: ACTIVE_COMPARATOR

thigh lift

Intervention Type: PROCEDURE

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

Interventions

thigh lift

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

Intervention Type: PROCEDURE

Other Intervention Names

thigh liposuction; liposuction assisted thigh lift

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mohammed Gamal

plastic surgery department, Assiut University Hospital, Assiut, Egypt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut university

Asyut, , Egypt

Countries

Egypt

References

Cabbabe SW. Plastic Surgery after Massive Weight Loss. Mo Med. 2016 May-Jun;113(3):202-6.

Reference Type: BACKGROUND

PMID: 27443046 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27219231 (View on PubMed)

Other Identifiers

13111987

Identifier Type: -

Identifier Source: org_study_id