ObesityNCT00831610
Post-bariatric Abdominoplasty: Skin Sensation Evaluation
A study testing Bariatric surgery (Roux-en-Y Gastric Bypass) + Post-bariatric abdominoplasty. and Roux-en-Y gastric bypass (bariatric surgery) + Post-bariatric abdominoplasty (without flap undermining) in people with Obesity and Hypesthesia, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 years, women only
- Conditions the study is for
- Obesity, Hypesthesia
- What is being tested?
- Bariatric surgery (Roux-en-Y Gastric Bypass) + Post-bariatric abdominoplasty. and Roux-en-Y gastric bypass (bariatric surgery) + Post-bariatric abdominoplasty (without flap undermining)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2006to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Diabetes.
- Peripheral neuropathy.
- Deny to sign the Informed Consent Term.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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?
- Conditions
- Obesity, Hypesthesia
- Being tested
- Bariatric surgery (Roux-en-Y Gastric Bypass) + Post-bariatric abdominoplasty., Roux-en-Y gastric bypass (bariatric surgery) + Post-bariatric abdominoplasty (without flap undermining)
- Keywords
- bariatric surgery, plastic surgery, abdominal wall, skin, sensation, abdominoplasty
- Medical subject headings
- Obesity, Hypesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgery (Roux-en-Y Gastric Bypass) + Post-bariatric abdominoplasty.Procedure or surgery
Also called Anchor-line abdominoplasty, Abdominoplasty, Post-bariatric plastic surgery
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)Procedure or surgery
Bariatric surgery Plastic surgery Abdominoplasty
| Study group | Role | What they receive |
|---|---|---|
| STUDY | Other | 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. Receives: 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) |
| CONTROL | Other | 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. Receives: Procedure: Roux-en-Y gastric bypass (bariatric surgery) + Post-bariatric abdominoplasty (without flap undermining) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Innocuous static tactile sensation in grams per square millimeters (g/mm2) by nylon monofilaments aesthesiometer.
Measured: Day before the surgical intervention and 6th month after for Study group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2009 (estimated)
- Study startAug 2006
- Primary completionOct 2008
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodolpho Alberto Bussolaro, MD. PhD., Federal University of São Paulo
- Investigators
- Rodolpho A Bussolaro, PhD fellow, Principal investigator, Federal University of São PauloElvio B Garcia, Professor, Study chair, Federal University of São PauloLydia M Ferreira, Chairwoman, Study director, Federal Universtity of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00831610
- Sponsor's protocol ID
- UNIFESP-712/06
- Status last verified
- May 2012
- First submitted
- 28 Jan 2009
- Last updated
- 28 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 18982397
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-bariatric Abdominoplasty: Skin Sensation Evaluation.
- ClinicalTrials.gov ID
- NCT00831610
- Acronym / sponsor ID
- UNIFESP-712/06
- Conditions
- Obesity, Hypesthesia
- Keywords
- bariatric surgery, plastic surgery, abdominal wall, skin, sensation, abdominoplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 29 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STUDY | Other | 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)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. |
| CONTROL | Other | Procedure: Roux-en-Y gastric bypass (bariatric surgery) + Post-bariatric 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. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Diabetes.
- Peripheral neuropathy.
- Deny to sign the Informed Consent Term.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric surgery (Roux-en-Y Gastric Bypass) + Post-bariatric abdominoplasty.Also: Anchor-line abdominoplasty, Abdominoplasty, Post-bariatric plastic surgerySurgical 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. | Procedure or surgery | STUDY |
| Roux-en-Y gastric bypass (bariatric surgery) + Post-bariatric abdominoplasty (without flap undermining)Bariatric surgery Plastic surgery Abdominoplasty | Procedure or surgery | CONTROL, STUDY |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2012.
- Results publication: PubMed 18982397Bussolaro 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodolpho A Bussolaro, PhD fellow principal investigator
Federal University of São Paulo
Elvio B Garcia, Professor study chair
Federal University of São Paulo
Lydia M Ferreira, Chairwoman study director
Federal Universtity of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bariatric surgery (Roux-en-Y Gastric Bypass) + Post-bariatric abdominoplasty. and Roux-en-Y gastric bypass (bariatric surgery) + Post-bariatric abdominoplasty (without flap undermining) in people with Obesity and Hypesthesia, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00831610, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2012.