Clinical trial NCT00831610: Post-bariatric Abdominoplasty: Skin Sensation Evaluation
Official title: Post-bariatric Abdominoplasty: Skin Sensation Evaluation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Hypesthesia
Keywords: bariatric surgery
plastic surgery
abdominal wall
skin
sensation
abdominoplasty
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2009-01-29
Enrollment: 100
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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?

Eligibility 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.

Primary outcomes:
measure: Innocuous static tactile sensation in grams per square millimeters (g/mm2) by nylon monofilaments aesthesiometer.
timeFrame: Day before the surgical intervention and 6th month after for Study group.
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal Universtiy of São Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Rodolpho A Bussolaro, PhD fellow
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Elvio B Garcia, Professor
role: STUDY_CHAIR
affiliation: Federal Universtity of São Paulo
name: Lydia M Ferreira, Chairwoman
role: STUDY_DIRECTOR
References:
citation: 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.