Post-bariatric Abdominoplasty: Skin Sensation Evaluation

Post-bariatric Abdominoplasty: Skin Sensation Evaluation.

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).

Study Overview

• Status: Completed
• Conditions: Obesity; Hypesthesia
• Intervention / Treatment: 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)

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 04023-002
    • Federal Universtiy of São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: STUDY; 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.; 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.; Other Names: Anchor-line abdominoplasty; Abdominoplasty; Post-bariatric plastic surgery; Procedure: Roux-en-Y gastric bypass (bariatric surgery) + Post-bariatric abdominoplasty (without flap undermining); Bariatric surgery Plastic surgery Abdominoplasty
OTHER: 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.	Procedure: Roux-en-Y gastric bypass (bariatric surgery) + Post-bariatric abdominoplasty (without flap undermining); Bariatric surgery Plastic surgery Abdominoplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Investigators: Principal Investigator: Rodolpho A Bussolaro, PhD fellow, Federal University of São Paulo; Study Chair: Elvio B Garcia, Professor, Federal University of São Paulo; Study Director: Lydia M Ferreira, Chairwoman, Federal Universtity of São Paulo

Publications and helpful links

General Publications

• 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.

Helpful Links

• Contact and further information about the investigators team.

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (ACTUAL): October 1, 2008
• Study Completion (ACTUAL): December 1, 2010

Study Registration Dates

• First Submitted: January 28, 2009
• First Submitted That Met QC Criteria: January 28, 2009
• First Posted (ESTIMATE): January 29, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): May 28, 2012
• Last Update Submitted That Met QC Criteria: May 25, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: skin; bariatric surgery; sensation; plastic surgery; abdominoplasty; abdominal wall
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Sensation Disorders; Somatosensory Disorders; Hypesthesia
• Other Study ID Numbers: UNIFESP-712/06