Post-bariatric Abdominoplasty: Skin Sensation Evaluation

Study Overview
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Brief Summary
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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).

Detailed Description
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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?

Official Title
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Post-bariatric Abdominoplasty: Skin Sensation Evaluation.

Conditions
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Obesity, Hypesthesia

Intervention / Treatment
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* 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)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: STUDY<br>Female healthy volunteers (25 to 55 years old) with normal weight. Morbid Obese women waiting for bariatric surgery. 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. Group 3, submitted to anchor-line abdominoplasty without flap undermining. | Procedure: Bariatric surgery (Roux-en-Y Gastric Bypass) + Post-bariatric abdominoplasty.<br>* 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.<br>* Other names: Post-bariatric plastic surgery;Procedure: Roux-en-Y gastric bypass (bariatric surgery) + Post-bariatric abdominoplasty (without flap undermining)<br>* Bariatric surgery Plastic surgery Abdominoplasty<br>|
| Other: CONTROL<br>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)<br>* Bariatric surgery Plastic surgery Abdominoplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Innocuous static tactile sensation in grams per square millimeters (g/mm2) by nylon monofilaments aesthesiometer. |  | Day before the surgical intervention and 6th month after for Study group. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bariatric surgery, plastic surgery, abdominal wall, skin, sensation, abdominoplasty