Clinical trial NCT02552433: Complications in Body Contouring Surgery
Official title: Complications in Post-bariatric Body Contouring Surgery; Prevalence With hands-on Treatment Regimen
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bariatric Surgery
Body Contouring Surgery
Keywords: nutritional deficiencies
plastic surgery
post-bariatric
protein
skin surplus
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
Collaborators: name: Catharina Ziekenhuis Eindhoven
First posted: 2015-09-17
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All post-bariatric patients with a stable weight and complaints of skin surplus can be referred to the department of Plastic and Reconstructive Surgery by the department of Bariatric Surgery or the general practitioner. After reference the treating plastic surgeon will decide whether there is an indication for BCS; the type and timing of the BCS will be at the discretion of the treating plastic surgeon. If a patient is eligible for BCS and meets the inclusion criteria the treating plastic surgeon or one of the physicians or a trained staff nurse of the plastic surgery department will explain the study and hand out patient information letter. In the second preoperative consultation informed consent will be performed.

Brief summary: The objective of this study is to describe the wound related complication rate in post-bariatric body contouring surgery patients who are treated according to the new Dutch guideline and to asses the factors associated with a higher complication rate.

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.

Eligibility criteria: 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

Primary outcomes:
measure: complication rate
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
state: Noord-Brabant
city: Nieuwegein
country: Netherlands
facility: Sint Antonius Hospital
state: Utrecht
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
Study officials:
affiliation: Sint Antonius Hospital
name: Aebele Mink van der Molen, MD/PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Catharina Ziekenhuis Eindhoven
name: Maarten Hoogbergen, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: