Clinical trial NCT02140385: Role of Preservation of Scarpa's Fascia in Abdominoplasty
Official title: Role of Preservation of Scarpa's Fascia in Abdominoplasty: a Prospective Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Abdominoplasty
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2014-05-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


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

Primary outcomes:
measure: Lymphatic preservation
timeFrame: Two weeks post-operatively
Secondary outcomes:
measure: Edema
timeFrame: Up to six months post-operatively
measure: Seroma formation
timeFrame: Up to six months post-operatively
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Department of Plastic and Reconstructive Surgery
state: California
Study officials:
affiliation: Loma Linda University Department of Plastic Surgery
name: Michael E Hill, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: