Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06427759
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-24
First Post:
2024-05-08
Brief Title:
Optimizing Aesthetic Outcome for Arm Contouring Surgery by Utilizing Anthropometric Measurements
Sponsor:
Abdelrahman Mostafa Shehata Mohammed
Organization:
Assiut University
Study Overview
Official Title:
Optimizing Aesthetic Outcome for Arm Contouring Surgery by Utilizing Anthropometric Measurements
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Brachioplasty is a popular plastic surgery procedure Current and common various techniques are based on either surgeon s sense preoperatively A method is needed to define how much skin and soft tissue should be excised precisely or what can be a reference point to design a brachioplasty mathematically1
Anthropometric reference measurements can be applied in designing arm aesthetic surgery
Classically anthropometry binds the upper arm length with forearm circumference and upper arm circumference to make postoperative results more harmonious and natural 2a 2020
Anthropometric reference measurements can be applied in designing arm aesthetic surgery
Classically anthropometry binds the upper arm length with forearm circumference and upper arm circumference to make postoperative results more harmonious and natural 2a 2020
Detailed Description:
241- Type of the study 24 2- Study Setting Plastic and Reconstructive Surgery Department Assuit University Hospital 24 3- Study subjects
a Inclusion criteria
Group A this group will be available for measurements only with no interventions needed
Group B Include patients asking for arm aesthetic surgery
Group B1 patients will be submitted for liposuction only liposuction is the preferred approach particularly in young patients after massive weight loss
Group B2 patients will be submitted for liposuction and brachioplasty in same setting When skin laxity is excessive even in young patients an extensive arm-long operation that extends across the axilla and onto the lateral chest is indicated
Group B3 patients will be submitted for liposuction then brachioplasty after 3 months
in borderline cases to take chance for skin retraction
c Sample Size Calculation sample size was calculated using g power program version 3197 in order to detect anthropometric measures of arm and compare these measures with post operative cases assumed effect size 08 based on clinical assumption novel study α error 02 power 08 and allocation 111 the sample size will be 40 patients for each group 244 -Study tools in detail eg lab methods instruments steps chemicals Group A will be subjected to these measures
Arm length Lateral length from acromion to lateral epicondyle Medial length from axilla to medial epicondyle
Arm circumference upper arm circumference Mid arm Lower arm
Forearm circumference at widest point Arm assessed with elbow flexed at 90 degree and shoulder abducted at 90 degree Group B will be subjected to
Group B1 patients will be submitted for liposuction only
Group B2 patients will be submitted for liposuction and brachioplasty in the same setting
Group B3 patients will be submitted for liposuction then brachioplasty after 3 6 and 12 months
Pre-operative Assessment
1 Patient history
2 History of massive weight loss or any operation
3 Preoperative investigations
4 Informed consent
5 Pre-operative photography operative technique - 1- most patients will take general anaesthesia 2- then sterilization with betadine solution 3 - pt positioned in supine position 4- patient will be subjected according to its group to groupA after injection of tumescent fluids - waiting 15 minutes - liposuction will be done circumferential in arm with cannula 4
groupB after injection of tumescent fluids in the medial part of arm onlyexcised part - waiting 15 minute - then excision of medial part according to pinch test
group C after injection of tumescent fluids all around _ waiting 15 minutes - liposuction will be done circumferential in arm with cannula 4
excision of the excessed part medially will be done after 3 months
Patients will be subjected to arm measures before and after operation
Arm length
Lateral length from acromion to lateral epicondyle Medial length from axilla to medial epicondyle
Arm circumference upper arm circumference Mid arm Lower arm
Forearm circumference at widest point Arm assessed with elbow flexed at 90 degree and shoulder abducted at 90 degree
Pinch Test
Excess skin
Site of maximum redundancyUpper - Middle - Lower arm
Grade of Lipodystrophy
Grade 1 minimal fat with no ptosis Grade 2A moderate fat with ptosis less than 5 cm Grade 2B moderate to severe fat with ptosis 5- 10 cm Grade 3 extreme fat with ptosis more than 10 cm Grade 4 mild to moderate fat with ptosis more than 10 cm 3 Then comparing of post operative measurements after 3 6 and 12 months with the anthropometric measures of group A
a Inclusion criteria
Group A this group will be available for measurements only with no interventions needed
Group B Include patients asking for arm aesthetic surgery
Group B1 patients will be submitted for liposuction only liposuction is the preferred approach particularly in young patients after massive weight loss
Group B2 patients will be submitted for liposuction and brachioplasty in same setting When skin laxity is excessive even in young patients an extensive arm-long operation that extends across the axilla and onto the lateral chest is indicated
Group B3 patients will be submitted for liposuction then brachioplasty after 3 months
in borderline cases to take chance for skin retraction
c Sample Size Calculation sample size was calculated using g power program version 3197 in order to detect anthropometric measures of arm and compare these measures with post operative cases assumed effect size 08 based on clinical assumption novel study α error 02 power 08 and allocation 111 the sample size will be 40 patients for each group 244 -Study tools in detail eg lab methods instruments steps chemicals Group A will be subjected to these measures
Arm length Lateral length from acromion to lateral epicondyle Medial length from axilla to medial epicondyle
Arm circumference upper arm circumference Mid arm Lower arm
Forearm circumference at widest point Arm assessed with elbow flexed at 90 degree and shoulder abducted at 90 degree Group B will be subjected to
Group B1 patients will be submitted for liposuction only
Group B2 patients will be submitted for liposuction and brachioplasty in the same setting
Group B3 patients will be submitted for liposuction then brachioplasty after 3 6 and 12 months
Pre-operative Assessment
1 Patient history
2 History of massive weight loss or any operation
3 Preoperative investigations
4 Informed consent
5 Pre-operative photography operative technique - 1- most patients will take general anaesthesia 2- then sterilization with betadine solution 3 - pt positioned in supine position 4- patient will be subjected according to its group to groupA after injection of tumescent fluids - waiting 15 minutes - liposuction will be done circumferential in arm with cannula 4
groupB after injection of tumescent fluids in the medial part of arm onlyexcised part - waiting 15 minute - then excision of medial part according to pinch test
group C after injection of tumescent fluids all around _ waiting 15 minutes - liposuction will be done circumferential in arm with cannula 4
excision of the excessed part medially will be done after 3 months
Patients will be subjected to arm measures before and after operation
Arm length
Lateral length from acromion to lateral epicondyle Medial length from axilla to medial epicondyle
Arm circumference upper arm circumference Mid arm Lower arm
Forearm circumference at widest point Arm assessed with elbow flexed at 90 degree and shoulder abducted at 90 degree
Pinch Test
Excess skin
Site of maximum redundancyUpper - Middle - Lower arm
Grade of Lipodystrophy
Grade 1 minimal fat with no ptosis Grade 2A moderate fat with ptosis less than 5 cm Grade 2B moderate to severe fat with ptosis 5- 10 cm Grade 3 extreme fat with ptosis more than 10 cm Grade 4 mild to moderate fat with ptosis more than 10 cm 3 Then comparing of post operative measurements after 3 6 and 12 months with the anthropometric measures of group A
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None