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Body Contouring Surgery After Massive Weight Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02174458
Recruitment Status : Completed
First Posted : June 25, 2014
Last Update Posted : March 18, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
Body contouring (BC) surgery after major weight loss (MWL) requires extensive and multiple procedures. Yet, there are inconsistent data regarding the outcome after BC procedures. The aim of this study is to investigate the outcome from patients who elect to have BC procedures after MWL treated at a single metropolitan tertiary referral center.

Condition or disease Intervention/treatment
Weight Loss Procedure: Body Contouring Surgery

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Study Type : Observational [Patient Registry]
Actual Enrollment : 23 participants
Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Outcome in Body Contouring Surgery After Major Weight Loss - a Prospective Matched Single Blind Study
Study Start Date : January 2014
Actual Primary Completion Date : May 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Bariatric Surgery only
Patients after Bariatric Surgery but no secondary reconstructive procedures
Body Contouring surgery
Post-bariatric patients and patients with no history of bariatric surgery but after natural weight loss
Procedure: Body Contouring Surgery
Patients after bariatric surgery (BS) and patients with no history of BS but after natural weight loss and some degree of skin laxity who underwent Body contouring will be included after written informed consent is obtained.
Other Name: Body Contouring Surgery is the excision of excess skin




Primary Outcome Measures :
  1. Quality of life after Body contouring Surgery [ Time Frame: 10 years ]
    The Moorehead-Ardelt(Oria and Moorehead, 1998) questionnaire is the HRQoL part of the "Bariatric Analysis and Reporting Outcome System". This questionnaire was created to specifically evaluate the outcome of bariatric surgery, and it is widely used by national and international bariatric surgery associations. It evaluates five domains of HRQoL: self-esteem, physical activity, social life, work ability and sexual activity. For each domain, patient evaluates "much better", "better", "same", "worse" or "much worse" his status on the time that he answers to the questionnaire in comparison to his status before bariatric surgery. Results are summarized in a total score (−3.0 to +3.0) which is the sum of the self-esteem score (−1 to +1) and the four other domains (−0.5 to +0.5 for each). Total score is estimated as "much better" (scores +2.25 to +3), "better" (+0.75 to +2), "same" (+0.5 to −0.5), "worse" (−0.75 to −2 points) and "much worse" (−2.25 to −3).(Modarressi et al., 2013)


Secondary Outcome Measures :
  1. Comparison of the sub-Domains of the Moorehead-Ardelt questionnaire after Body Contouring Surgery [ Time Frame: 10 Years ]
    Comparisons between the five domains of the Moorehead-Ardelt questionnaire Drop-out rate



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Post-bariatric male and female patients and patients with no history of bariatric surgery but after natural weight loss and some degree of skin laxity who underwent body-contouring surgery between February 1999 and October 2009 at the Department of Plastic, Reconstructive and Aesthetic Surgery, Handsurgery, University Hospital of Basel will be included. Patients after BS with equal distributions and demographic characteristics but no secondary reconstructive procedures served as a control group.
Criteria

Inclusion Criteria:

  • Weight loss > 15kg
  • Age > 18 years

Exclusion Criteria:

  • Weight loss < 15kg
  • Age < 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174458


Locations
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Switzerland
University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Daniel F Kalbermatten, MD, PhD University Hospital, Basel, Switzerland
Additional Information:

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02174458    
Other Study ID Numbers: BC_QoL_EK_311/13
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015
Keywords provided by University Hospital, Basel, Switzerland:
Bariatric surgery; Body contouring; Quality of life
Additional relevant MeSH terms:
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Body Weight
Weight Loss
Signs and Symptoms
Body Weight Changes