Post-Bariatric Abdominoplasty: Skin Sensation Evaluation - Full Text View

Sponsored by:	Federal University of São Paulo
Information provided by:	Federal University of São Paulo
ClinicalTrials.gov Identifier:	NCT00831610

Purpose

The purpose of this study is to quantify the skin sensation of the anterior abdominal wall of the post-bariatric patients submitted to anchor-line abdominoplasty without flap undermining.

Condition	Intervention
Obesity Hypesthesia	Procedure: Post-bariatric abdominoplasty

MedlinePlus related topics: Obesity Surgery

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Post-Bariatric Abdominoplasty: Skin Sensation Evaluation.

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:

Innocuous static tactile sensation in grams per square millimeters (g/mm2) by nylon monofilaments aesthesiometer. [ Time Frame: Day before the surgical intervention and 6th month after for Study group. ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	51
Study Start Date:	August 2006
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
STUDY Post-bariatric female patients, 25 to 55 years old, MORE than 12 months of weight stability, pendular abdominal wall, clinical conditions to anchor-line abdominoplasty without flap undermining.	Procedure: Post-bariatric abdominoplasty Surgical removal of the exceeding skin and adiposity of the abdominal wall by one midline vertical fuse and one supra-pubic horizontal fuse. Skin suture without flap undermining and with low tension.
CONTROL Post-bariatric female patients, 25 to 55 years old, LESS than 12 months of weight stability, pendular abdominal wall, clinical conditions to anchor-line abdominoplasty without flap undermining. Who will be submitted to abdominoplasty after the study period.

Detailed Description:

Abdominoplasty performed in post-bariatric patients presents more post-operative complications than in non post-bariatric patients. Surgical techniques that provokes less complications are required. Anchor-line abdominoplasty is a technique published in the years 1950 as well the first bariatric proceedings. Abdominoplasty without flap undermining is feasible in pendular abdominal wall of the former morbidly obese women with scarred abdomen.

Classical abdominoplasty (with flap undermining) is known to impair significantly the skin sensation. Post-bariatric abdominoplasty without flap undermining keeps the skin sensation unaltered since the early post-operative period.

Now that the post-bariatric anchor-line abdominoplasty improves the abdominal wall contour by removing the exceeding, pendular and striated skin saving the perforant skin sensory nerves. Could this technique improve the skin sensation of the anterior abdominal wall of the post-bariatric patients?

Eligibility

Ages Eligible for Study:	25 Years to 55 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Former morbidly obese adult patients. After Roux en Y gastric bypass. Female patients. Pendular abdominal wall deformity. 25 to 55 years old.

Criteria

Inclusion Criteria:

Former morbidly obese women with Body Mass Index superior of 40kg/m2.
Post-bariatric surgery: Roux en Y gastric bypass.
Clinical conditions to perform a plastic surgery.

Exclusion Criteria:

Diabetes.
Peripheral neuropathy.
Deny to sign the Informed Consent Term.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00831610

Locations

Brazil
Federal Universtiy of São Paulo
São Paulo, Brazil, 04023-002

Sponsors and Collaborators

Federal University of São Paulo

Investigators

Principal Investigator:	Rodolpho A Bussolaro, PhD fellow	Federal University of São Paulo
Study Chair:	Elvio B Garcia, Professor	Federal University of São Paulo
Study Director:	Lydia M Ferreira, Chairwoman	Federal Universtity of São Paulo

More Information

Additional Information:

Contact and further information about the investigators team. This link exits the ClinicalTrials.gov site

Institutional ethics committee web-site. This link exits the ClinicalTrials.gov site

Publications:

Bussolaro RA, Garcia EB, Barbosa MV, Omonte IR, Huijsmans JP, Bariani RL, Ferreira LM. Post-Bariatric Abdominoplasty: Skin Sensation Evaluation. Obes Surg. 2008 Nov 4; [Epub ahead of print]

Responsible Party:	Federal Universtity of São Paulo ( Lydia Masako Ferreira )
Study ID Numbers:	UNIFESP-712/06
Study First Received:	January 28, 2009
Last Updated:	January 28, 2009
ClinicalTrials.gov Identifier:	NCT00831610 History of Changes
Health Authority:	Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:

bariatric surgery
plastic surgery
abdominal wall

skin
sensation
abdominoplasty

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Sensation Disorders
Somatosensory Disorders
Obesity

Hypesthesia
Nutrition Disorders
Neurologic Manifestations
Overweight
Overnutrition

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Sensation Disorders
Somatosensory Disorders
Obesity
Hypesthesia

Nervous System Diseases
Nutrition Disorders
Neurologic Manifestations
Overweight
Overnutrition

ClinicalTrials.gov processed this record on May 06, 2009