Post-bariatric Abdominoplasty: Skin Sensation Evaluation

Not Applicable

Completed

• Conditions: Obesity; Hypesthesia
• 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)

• Registration Number: NCT00831610
• Lead Sponsor: Federal University of São Paulo

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).

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 Timeline

• Study Start: 2006-08
• Primary Completion: 2008-10
• Study First Submitted: 2009-01-28
• Study First Submitted QC: 2009-01-28
• Study First Posted: 2009-01-29
• Study Completion: 2010-12
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-25
• Last Update Posted: 2012-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STUDY	Bariatric surgery (Roux-en-Y Gastric Bypass) + Post-bariatric abdominoplasty.	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.
STUDY	Roux-en-Y gastric bypass (bariatric surgery) + Post-bariatric abdominoplasty (without flap undermining)	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.
CONTROL	Roux-en-Y gastric bypass (bariatric surgery) + Post-bariatric abdominoplasty (without flap undermining)	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Federal Universtiy of São Paulo; 🇧🇷 São Paulo, Brazil