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Post-bariatric Abdominoplasty: Skin Sensation Evaluation

Primary Purpose

Obesity, Hypesthesia

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Bariatric surgery (Roux-en-Y Gastric Bypass) + Post-bariatric abdominoplasty.
Roux-en-Y gastric bypass (bariatric surgery) + Post-bariatric abdominoplasty (without flap undermining)
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obesity focused on measuring bariatric surgery, plastic surgery, abdominal wall, skin, sensation, abdominoplasty

Eligibility Criteria

25 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Federal Universtiy of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

STUDY

CONTROL

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Innocuous static tactile sensation in grams per square millimeters (g/mm2) by nylon monofilaments aesthesiometer.

Secondary Outcome Measures

Full Information

First Posted
January 28, 2009
Last Updated
May 25, 2012
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00831610
Brief Title
Post-bariatric Abdominoplasty: Skin Sensation Evaluation
Official Title
Post-bariatric Abdominoplasty: Skin Sensation Evaluation.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Hypesthesia
Keywords
bariatric surgery, plastic surgery, abdominal wall, skin, sensation, abdominoplasty

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
STUDY
Arm Type
Other
Arm Description
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.
Arm Title
CONTROL
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Bariatric surgery (Roux-en-Y Gastric Bypass) + Post-bariatric abdominoplasty.
Other Intervention Name(s)
Anchor-line abdominoplasty, Abdominoplasty, Post-bariatric plastic surgery
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Roux-en-Y gastric bypass (bariatric surgery) + Post-bariatric abdominoplasty (without flap undermining)
Intervention Description
Bariatric surgery Plastic surgery Abdominoplasty
Primary Outcome Measure Information:
Title
Innocuous static tactile sensation in grams per square millimeters (g/mm2) by nylon monofilaments aesthesiometer.
Time Frame
Day before the surgical intervention and 6th month after for Study group.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodolpho A Bussolaro, PhD fellow
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elvio B Garcia, Professor
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lydia M Ferreira, Chairwoman
Organizational Affiliation
Federal Universtity of São Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Federal Universtiy of São Paulo
City
São Paulo
ZIP/Postal Code
04023-002
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
18982397
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.
Results Reference
result
Links:
URL
http://www.posgrad.epm.br/plastica/
Description
Contact and further information about the investigators team.

Learn more about this trial

Post-bariatric Abdominoplasty: Skin Sensation Evaluation

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