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Post-bariatric Abdominoplasty: Skin Sensation Evaluation

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ClinicalTrials.gov Identifier: NCT00831610
Recruitment Status : Completed
First Posted : January 29, 2009
Last Update Posted : May 28, 2012
Sponsor:
Information provided by (Responsible Party):
Rodolpho Alberto Bussolaro, MD. PhD., Federal University of São Paulo

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
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) Not Applicable

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?

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Post-bariatric Abdominoplasty: Skin Sensation Evaluation.
Study Start Date : August 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : December 2010

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]

Eligibility Criteria
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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00831610


Locations
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Brazil
Federal Universtiy of São Paulo
São Paulo, Brazil, 04023-002
Sponsors and Collaborators
Federal University of São Paulo
Investigators
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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
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Additional Information:

Publications of Results:

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Responsible Party: Rodolpho Alberto Bussolaro, MD. PhD., Doctor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT00831610    
Other Study ID Numbers: UNIFESP-712/06
First Posted: January 29, 2009    Key Record Dates
Last Update Posted: May 28, 2012
Last Verified: May 2012
Keywords provided by Rodolpho Alberto Bussolaro, MD. PhD., Federal University of São Paulo:
bariatric surgery
plastic surgery
abdominal wall
 skin
sensation
abdominoplasty
Additional relevant MeSH terms:
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Hypesthesia
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases