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Post-bariatric Abdominoplasty: Skin Sensation Evaluation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rodolpho Alberto Bussolaro, MD. PhD., Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00831610
First received: January 28, 2009
Last updated: May 25, 2012
Last verified: May 2012
History of Changes
  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.

Additional purposes were: quantify topographically the abdominal skin sensation of the Normal weight, Morbid Obese and Former Morbid Obese after bariatric surgery (before and after the abdominoplasty - excess skin surgical removal without flap undermining -> Anchor Line Abdominoplasty).


Condition Intervention
Obesity
Hypesthesia
 Procedure: Bariatric surgery (Roux-en-Y Gastric Bypass) + Post-bariatric abdominoplasty.
Procedure: Roux-en-Y gastric bypass (bariatric surgery) + Post-bariatric abdominoplasty (without flap undermining)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Post-bariatric Abdominoplasty: Skin Sensation Evaluation.

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 100
Study Start Date: August 2006
Study Completion Date: December 2010
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
STUDY
  1. Female healthy volunteers (25 to 55 years old) with normal weight.
  2. Morbid Obese women waiting for bariatric surgery.
  3. 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. Skin Evaluation before the abdominoplasty.
  4. Group 3, submitted to anchor-line abdominoplasty without flap undermining.
 Procedure: Bariatric surgery (Roux-en-Y Gastric Bypass) + 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.
Other Names:
  • Anchor-line abdominoplasty
  • Abdominoplasty
  • Post-bariatric plastic surgery
Procedure: Roux-en-Y gastric bypass (bariatric surgery) + Post-bariatric abdominoplasty (without flap undermining)
Bariatric surgery Plastic surgery Abdominoplasty
CONTROL
Group 3: 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.
 Procedure: Roux-en-Y gastric bypass (bariatric surgery) + Post-bariatric abdominoplasty (without flap undermining)
Bariatric surgery Plastic surgery Abdominoplasty

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
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:

Responsible Party: Rodolpho Alberto Bussolaro, MD. PhD., Doctor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT00831610     History of Changes
Other Study ID Numbers: UNIFESP-712/06
Study First Received: January 28, 2009
Last Updated: May 25, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
bariatric surgery
plastic surgery
abdominal wall
 skin
sensation
abdominoplasty

Additional relevant MeSH terms:
Hypesthesia
Obesity
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
 Signs and Symptoms
Overnutrition
Nutrition Disorders
Overweight
Body Weight

ClinicalTrials.gov processed this record on June 17, 2013