Role of Preservation of Scarpa's Fascia in Abdominoplasty

Loma Linda University (LLU)

Status: Withdrawn

Conditions: Abdominoplasty

Treatments: Device: Lymphoscintigraphy; Device: Abdominal ultrasound; Procedure: Abdominoplasty-Scarpa's fascia ablation; Device: 3D Imaging; Procedure: Abdominoplasty-Scarpa's fascia preservation

Study type: Interventional

Funder types: Other

Identifiers

NCT02140385

5120289

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups

Abdominoplasty-Scarpa's fascia preservation

Active Comparator group

Description:

Scarpa's fascia preservation Lymphoscintigraphy 3D imaging Abdominal ultrasound

Treatment:

Device: Abdominal ultrasound

Device: Lymphoscintigraphy

Procedure: Abdominoplasty-Scarpa's fascia preservation

Device: 3D Imaging

Abdominoplasty-Scarpa's fascia ablation

Active Comparator group

Description:

Scarpa's fascia ablation Lymphoscintigraphy 3D imaging Abdominal ultrasound

Treatment:

Procedure: Abdominoplasty-Scarpa's fascia ablation

Device: Abdominal ultrasound

Device: Lymphoscintigraphy

Device: 3D Imaging