NCT00831610

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Aug 2006

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 29, 2009

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

May 28, 2012

Status Verified

May 1, 2012

Enrollment Period

2.2 years

First QC Date

January 28, 2009

Last Update Submit

May 25, 2012

Conditions

ObesityHypesthesia

Keywords

bariatric surgeryplastic surgeryabdominal wallskinsensationabdominoplasty

Outcome Measures

Primary Outcomes (1)

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

    Day before the surgical intervention and 6th month after for Study group.

Study Arms (2)

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.

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.

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

Interventions

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.

Also known as: Anchor-line abdominoplasty, Abdominoplasty, Post-bariatric plastic surgery
STUDY
Roux-en-Y gastric bypass (bariatric surgery) + Post-bariatric abdominoplasty (without flap undermining)PROCEDURE

Bariatric surgery Plastic surgery Abdominoplasty

CONTROLSTUDY

Eligibility Criteria

Age25 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Diabetes.
  • Peripheral neuropathy.
  • Deny to sign the Informed Consent Term.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal Universtiy of São Paulo

São Paulo, São Paulo, 04023-002, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 18982397RESULT

Related Links

MeSH Terms

Conditions

ObesityHypesthesia

Interventions

Bariatric SurgeryGastric BypassAbdominoplasty

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSomatosensory DisordersSensation DisordersNeurologic ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, OperativeGastroenterostomyAnastomosis, SurgicalDigestive System Surgical ProceduresCosmetic TechniquesPlastic Surgery Procedures

Study Officials

  • Rodolpho A Bussolaro, PhD fellow

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

  • Elvio B Garcia, Professor

    Federal University of São Paulo

    STUDY CHAIR

  • Lydia M Ferreira, Chairwoman

    Federal Universtity of São Paulo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

January 28, 2009

First Posted

January 29, 2009

Study Start

August 1, 2006

Primary Completion

October 1, 2008

Study Completion

December 1, 2010

Last Updated

May 28, 2012

Record last verified: 2012-05

Locations

BR(1)