- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02552433
Complications in Body Contouring Surgery (CONTOUR)
Complications in Post-bariatric Body Contouring Surgery; Prevalence With hands-on Treatment Regimen
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In the recently published guideline of the Dutch Association of Plastic Surgeons it is advised that assessment and improvement of the nutritional status should be part of pre-operative work-up of all post-bariatric patients who undergo body contouring surgery (BCS). The assessment should consist of consultation of a dietician and measurement of the nutritional parameters associated with wound healing. It is advised to assess the following parameters:
- albumin
- hemoglobin
- vitamin D (25-hydroxy vitamin D)
- ferritin
- folic acid
- vitamin B12
Standard treatment in this study will consist of the pre-operative work-up as advised by the guideline. Participants will have a consultation with the dietician to assess (protein) intake. In addition the first blood sample, which is part of standard treatment according to the new protocol, will be obtained to assess foregoing parameters. If there are nutritional deficiencies they will be treated according to the protocol of the department of Bariatric Surgery of the treating hospital.
To evaluate the effect of the treatment of deficiencies and to be sure that there are no deficiencies present during the BCS a second blood sample will be drawn during the body contouring procedure. For study purposes this second sample will be collected in all patients, even if a deficiency was not present at the first blood sample.
The dietician will assess current intake of the patients, with special attention the protein intake. Based on guidelines on protein-intake in post-bariatric patients and after consultation of experts (Dieticians of Maastricht University) investigators decided that the aim of the minimum protein intake is 1.5 gram per kilogram bodyweight (calculated with BMI 27kg/m2) per day. The first consultation at the dietician will be eight weeks prior to surgery. Patients will be advised to start with the extra protein-intake four weeks prior to surgery and continue this until the wounds are completely healed.
Six weeks after surgery a questionnaire will be handed-out to the patients, to assess the compliance to the treatment regime.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Arnhem, Netherlands
- Rijnstate Hospital
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Noord-Brabant
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Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
- Catharina hospital
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Utrecht
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Nieuwegein, Utrecht, Netherlands, 3430 EM
- Sint Antonius Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- post-bariatric patient
- undergoing BCS because of skin surplus
- contouring in one of the following regions: abdomen, mammae, legs, arms, upper body or lower body.
Exclusion Criteria:
- BMI higher than 34.9 kg/m2
- weight unstable in last 12 months
- diabetes mellitus defined by currently using either oral medication or insulin
- active smoker
- using immunosuppressive drugs, e.g. corticosteroids, methotrexate
- using anti-coagulants other than acetylsalicylic acid
- coagulopathy, vasculitis, connective tissue disorder
- kidney failure (GFR<30) or liver failure
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Body Contouring Surgery
All patients who undergo BCS after bariatric surgery.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
complication rate
Time Frame: 30 days
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wound related complication rate
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30 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Aebele Mink van der Molen, MD/PhD, Sint Antonius Hospital
- Principal Investigator: Maarten Hoogbergen, MD/PhD, Catharina Ziekenhuis Eindhoven
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R15.035
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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