Post-bariatric Abdominoplasty: Skin Sensation Evaluation
| Tracking Information | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | January 28, 2009 | ||||||||||||
| Last Updated Date | May 25, 2012 | ||||||||||||
| Start Date ICMJE | August 2006 | ||||||||||||
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
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. ] [ Designated as safety issue: Yes ] | ||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT00831610 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Post-bariatric Abdominoplasty: Skin Sensation Evaluation | ||||||||||||
| Official Title ICMJE | Post-bariatric Abdominoplasty: Skin Sensation Evaluation. | ||||||||||||
| 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? |
||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase | Not Provided | ||||||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
||||||||||||
| Condition ICMJE |
|
||||||||||||
| Intervention ICMJE |
|
||||||||||||
| Study Arm (s) |
|
||||||||||||
| Publications * | Bussolaro RA, Garcia EB, Barbosa MV, Omonte IR, Huijsmans JP, Bariani RL, Ferreira LM. Post-Bariatric Abdominoplasty: Skin Sensation Evaluation. Obes Surg. 2008 Nov 4; [Epub ahead of print] | ||||||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||||||
| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Enrollment ICMJE | 100 | ||||||||||||
| Completion Date | December 2010 | ||||||||||||
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||||||
| Gender | Female | ||||||||||||
| Ages | 25 Years to 55 Years | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | Brazil | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT00831610 | ||||||||||||
| Other Study ID Numbers ICMJE | UNIFESP-712/06 | ||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||
| Responsible Party | Rodolpho Alberto Bussolaro, MD. PhD., Federal University of São Paulo | ||||||||||||
| Study Sponsor ICMJE | Federal University of São Paulo | ||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||
| Investigators ICMJE |
|
||||||||||||
| Information Provided By | Federal University of São Paulo | ||||||||||||
| Verification Date | May 2012 | ||||||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||||||