Post-bariatric Abdominoplasty: Skin Sensation Evaluation

NCT ID: NCT00831610

Last Updated: 2012-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2010-12-31

Brief Summary

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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

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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?

Conditions

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Obesity Hypesthesia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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STUDY

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.

Group Type OTHER

Bariatric surgery (Roux-en-Y Gastric Bypass) + Post-bariatric abdominoplasty.

Intervention Type PROCEDURE

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)

Intervention Type PROCEDURE

Bariatric surgery Plastic surgery Abdominoplasty

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.

Group Type OTHER

Roux-en-Y gastric bypass (bariatric surgery) + Post-bariatric abdominoplasty (without flap undermining)

Intervention Type PROCEDURE

Bariatric surgery Plastic surgery Abdominoplasty

Interventions

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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.

Intervention Type PROCEDURE

Roux-en-Y gastric bypass (bariatric surgery) + Post-bariatric abdominoplasty (without flap undermining)

Bariatric surgery Plastic surgery Abdominoplasty

Intervention Type PROCEDURE

Other Intervention Names

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Anchor-line abdominoplasty Abdominoplasty Post-bariatric plastic surgery

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Rodolpho Alberto Bussolaro, MD. PhD.

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rodolpho A Bussolaro, PhD fellow

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Elvio B Garcia, Professor

Role: STUDY_CHAIR

Federal University of São Paulo

Lydia M Ferreira, Chairwoman

Role: STUDY_DIRECTOR

Federal Universtity of São Paulo

Locations

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Federal Universtiy of São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type RESULT
PMID: 18982397 (View on PubMed)

Related Links

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Other Identifiers

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UNIFESP-712/06

Identifier Type: -

Identifier Source: org_study_id

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