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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03283475
Other study ID # 13111987
Secondary ID
Status Active, not recruiting
Phase N/A
First received September 13, 2017
Last updated September 13, 2017
Start date May 14, 2017
Est. completion date April 1, 2019

Study information

Verified date September 2017
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 90
Est. completion date April 1, 2019
Est. primary completion date October 22, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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

Locations

Country Name City State
Egypt Assiut university Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Cabbabe SW. Plastic Surgery after Massive Weight Loss. Mo Med. 2016 May-Jun;113(3):202-6. Review. — View 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):1748-57. doi: 10.1097/PRS.0000000000002194. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 3 months
Secondary 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.
1 week and 3 months