Post-bariatric Abdominoplasty: Skin Sensation Evaluation

Obesity Clinical Trial

Official title:

Post-bariatric Abdominoplasty: Skin Sensation Evaluation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00831610
• Other study ID #: UNIFESP-712/06
• Status: Completed
• Phase: N/A
• First received: January 28, 2009
• Last updated: May 25, 2012
• Start date: August 2006
• Est. completion date: December 2010

Study information

• Verified date: May 2012
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2010
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 55 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hypesthesia
• Obesity

Intervention

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.
• Roux-en-Y gastric bypass (bariatric surgery) + Post-bariatric abdominoplasty (without flap undermining)
Bariatric surgery Plastic surgery Abdominoplasty

Locations

Country	Name	City	State
Brazil	Federal Universtiy of São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes

External Links

•   Contact and further information about the investigators team.