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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

January 28, 2009
May 25, 2012
August 2006
October 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00831610 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Post-bariatric Abdominoplasty: Skin Sensation Evaluation
Post-bariatric Abdominoplasty: Skin Sensation Evaluation.

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).

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?

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Obesity
  • Hypesthesia
  • 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
  • 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.
    Interventions:
    • 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)
  • 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.
    Intervention: Procedure: Roux-en-Y gastric bypass (bariatric surgery) + Post-bariatric abdominoplasty (without flap undermining)
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]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
December 2010
October 2008   (final data collection date for primary outcome measure)

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.
Female
25 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00831610
UNIFESP-712/06
Yes
Rodolpho Alberto Bussolaro, MD. PhD., Federal University of São Paulo
Federal University of São Paulo
Not Provided
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
Federal University of São Paulo
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP