Post-bariatric Abdominoplasty: Skin Sensation Evaluation
NCT ID: NCT00831610
Last Updated: 2012-05-28
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
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COMPLETED
NA
100 participants
INTERVENTIONAL
2006-08-31
2010-12-31
Brief Summary
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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).
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Detailed Description
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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?
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
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.
Roux-en-Y gastric bypass (bariatric surgery) + Post-bariatric abdominoplasty (without flap undermining)
Bariatric surgery Plastic surgery Abdominoplasty
Interventions
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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.
Roux-en-Y gastric bypass (bariatric surgery) + Post-bariatric abdominoplasty (without flap undermining)
Bariatric surgery Plastic surgery Abdominoplasty
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Post-bariatric surgery: Roux en Y gastric bypass.
* Clinical conditions to perform a plastic surgery.
Exclusion Criteria
* Peripheral neuropathy.
* Deny to sign the Informed Consent Term.
25 Years
55 Years
FEMALE
No
Sponsors
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Federal University of São Paulo
OTHER
Responsible Party
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Rodolpho Alberto Bussolaro, MD. PhD.
Doctor
Principal Investigators
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Rodolpho A Bussolaro, PhD fellow
Role: PRINCIPAL_INVESTIGATOR
Federal University of São Paulo
Elvio B Garcia, Professor
Role: STUDY_CHAIR
Federal University of São Paulo
Lydia M Ferreira, Chairwoman
Role: STUDY_DIRECTOR
Federal Universtity of São Paulo
Locations
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Federal Universtiy of São Paulo
São Paulo, São Paulo, Brazil
Countries
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References
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Bussolaro RA, Garcia EB, Barbosa MV, Omonte IR, Huijsmans JP, Bariani RL, Ferreira LM. Post-bariatric abdominoplasty: skin sensation evaluation. Obes Surg. 2010 Jul;20(7):855-60. doi: 10.1007/s11695-008-9747-9. Epub 2008 Nov 4.
Related Links
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Institutional ethics committee web-site.
Other Identifiers
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UNIFESP-712/06
Identifier Type: -
Identifier Source: org_study_id
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