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Completed

NCT Number: NCT00831610

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).

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Key information

Conditions

Obesity Body Weight Hypesthesia Nervous System Diseases Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

25 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Federal Universtiy of São Paulo

São Paulo, 04023-002, Brazil

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Other names: Anchor-line abdominoplasty, Abdominoplasty, Post-bariatric plastic surgery

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

Procedure

Bariatric surgery Plastic surgery Abdominoplasty

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

Post-bariatric Abdominoplasty: Skin Sensation Evaluation.

Important dates

Study start
2006
Primary completion
2008
Study completion
2010
First posted
Jan 29, 2009
Registry last updated
May 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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