Role of Preservation of Scarpa's Fascia in Abdominoplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether leaving a thicker layer -which preserves the tissue called Scarpa's fascia -intact during an abdominoplasty (tummy tuck) decreases the damage to the lymphatic system. In order to investigate the effect of leaving a thinner or slightly thicker layer intact during a tummy tuck, patients who are already planning to undergo the surgery, and who agree to participate, will be randomly assigned to two groups in a manner similar to flipping a coin. The first group will have their abdominoplasty performed with a thinner layer of abdominal wall left in place while the second group will have the surgery with a slightly thicker layer left in place. Both methods of doing a tummy tuck meet acceptable standards of care, and the aesthetic outcomes will not be negatively impacted by either of the options. Before and after the surgery, a procedure called lymphoscintigraphy will be performed. Lymphoscintigraphy is a special type of imaging where a dye, called a radiotracer, is injected and then detected by a special camera. The pictures provided by the lymphoscintigraphy allow investigators to look at the lymphatic system, which is a small network similar to blood vessels that helps drain extra fluid. The lymphoscintigraphy will help investigators to know what method of performing the tummy tuck leaves the lymphatic system most intact. In addition, photographs of each patient's abdomen will be taken using a special camera that allows investigators to put the photographs in the computer and compile a 3-dimensional image. Investigators will be able to look at the volume changes from swelling after the surgery using these pictures. Finally, an ultrasound will be used to help identify any seromas, or fluid collections, that may form after the surgery. The lymphoscintigraphy, photographs and the ultrasound combined will help determine whether or not leaving a thicker or thinner layer during a tummy tuck helps preserve the fluid draining lymphatic system and whether or not that effects recovery after the procedure.

Official Title
-----------------
Role of Preservation of Scarpa's Fascia in Abdominoplasty: a Prospective Trial

Conditions
-----------------
Abdominoplasty

Intervention / Treatment
-----------------
* Procedure: Abdominoplasty-Scarpa's fascia preservation
* Procedure: Abdominoplasty-Scarpa's fascia ablation
* Device: Lymphoscintigraphy
* Device: 3D Imaging
* Device: Abdominal ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients ages 18-65 years who are planning to undergo elective abdominoplasty Exclusion Criteria: patients with contraindications to lymphoscintigraphy patients with contraindications to abdominoplasty previous abdominal surgery or traumatic perforation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Abdominoplasty-Scarpa's fascia preservation<br>Scarpa's fascia preservation Lymphoscintigraphy 3D imaging Abdominal ultrasound | Procedure: Abdominoplasty-Scarpa's fascia preservation<br>* Thicker abdominal flaps will be preserved during the surgery.<br>Device: Lymphoscintigraphy<br>* Post-operative lymphatic imaging will be conducted using a common radiographic medium<br>Device: 3D Imaging<br>* Post-operative 3-dimensional photography will take place at a regularly scheduled clinic appointment.<br>Device: Abdominal ultrasound<br>* Post-operative abdominal ultrasound will be used to determine the presence of fluid collections (seromas).<br>|
| Active Comparator: Abdominoplasty-Scarpa's fascia ablation<br>Scarpa's fascia ablation Lymphoscintigraphy 3D imaging Abdominal ultrasound | Procedure: Abdominoplasty-Scarpa's fascia ablation<br>* Thinner abdominal flaps will be preserved during surgery.<br>Device: Lymphoscintigraphy<br>* Post-operative lymphatic imaging will be conducted using a common radiographic medium<br>Device: 3D Imaging<br>* Post-operative 3-dimensional photography will take place at a regularly scheduled clinic appointment.<br>Device: Abdominal ultrasound<br>* Post-operative abdominal ultrasound will be used to determine the presence of fluid collections (seromas).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lymphatic preservation | Lymphatic integrity will be measured pre-operatively and then again two weeks post-operatively in order to evaluate preservation of the lymphatic system. | Two weeks post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Edema | Edema will be measured by calculating volumetry using 3-dimensional photography | Up to six months post-operatively | 
| Seroma formation | Seroma formation will be evaluated by ultrasound at routine post-operative clinic appointments | Up to six months post-operatively |