Role of Preservation of Scarpa's Fascia in Abdominoplasty
NCT ID: NCT02140385
Last Updated: 2015-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
NA
INTERVENTIONAL
2014-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Transversus Abdominis Plane (TAP) Block Laparoscopic Hysterectomy
NCT01074229
Pre Operative Transversus Abdominis Plane Block Laparoscopic Gynecological Surgery
NCT01075074
Elastic Abdominal Binder After Open Abdominal Surgery for Benign Gynecologic Conditions
NCT03820115
TLH With Prior Uterine Artery Clipping at Its Origin Versus Conventional TLH
NCT05028543
Impact of Uterine and Ovarian Vessel Occlusion on Blood Loss in High Burden Minimally Invasive Myomectomy.
NCT07182045
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Abdominoplasty-Scarpa's fascia preservation
Scarpa's fascia preservation Lymphoscintigraphy 3D imaging Abdominal ultrasound
Abdominoplasty-Scarpa's fascia preservation
Thicker abdominal flaps will be preserved during the surgery.
Lymphoscintigraphy
Post-operative lymphatic imaging will be conducted using a common radiographic medium
3D Imaging
Post-operative 3-dimensional photography will take place at a regularly scheduled clinic appointment.
Abdominal ultrasound
Post-operative abdominal ultrasound will be used to determine the presence of fluid collections (seromas).
Abdominoplasty-Scarpa's fascia ablation
Scarpa's fascia ablation Lymphoscintigraphy 3D imaging Abdominal ultrasound
Abdominoplasty-Scarpa's fascia ablation
Thinner abdominal flaps will be preserved during surgery.
Lymphoscintigraphy
Post-operative lymphatic imaging will be conducted using a common radiographic medium
3D Imaging
Post-operative 3-dimensional photography will take place at a regularly scheduled clinic appointment.
Abdominal ultrasound
Post-operative abdominal ultrasound will be used to determine the presence of fluid collections (seromas).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Abdominoplasty-Scarpa's fascia preservation
Thicker abdominal flaps will be preserved during the surgery.
Abdominoplasty-Scarpa's fascia ablation
Thinner abdominal flaps will be preserved during surgery.
Lymphoscintigraphy
Post-operative lymphatic imaging will be conducted using a common radiographic medium
3D Imaging
Post-operative 3-dimensional photography will take place at a regularly scheduled clinic appointment.
Abdominal ultrasound
Post-operative abdominal ultrasound will be used to determine the presence of fluid collections (seromas).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* patients with contraindications to abdominoplasty
* previous abdominal surgery or traumatic perforation
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Loma Linda University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael E Hill, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Loma Linda University Department of Plastic Surgery
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Loma Linda University Department of Plastic and Reconstructive Surgery
Loma Linda, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
5120289
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.