Complications in Body Contouring Surgery

Complications in Post-bariatric Body Contouring Surgery; Prevalence With hands-on Treatment Regimen

Sponsors

Lead Sponsor: St. Antonius Hospital

Collaborator: Catharina Ziekenhuis Eindhoven

Source St. Antonius Hospital
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.

Overall Status Unknown status
Start Date 2015-09-01
Completion Date 2019-09-01
Primary Completion Date 2019-09-01
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
complication rate 30 days
Enrollment 160
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: protein intake assessment and optimisation

Arm Group Label: Body Contouring Surgery

Eligibility

Sampling Method:

Non-Probability Sample

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Location
Facility:
Catharina Hospital | Eindhoven, Noord-Brabant, 5623 EJ, Netherlands
Sint Antonius Hospital | Nieuwegein, Utrecht, 3430 EM, Netherlands
Rijnstate Hospital | Arnhem, Netherlands
Location Countries

Netherlands

Verification Date

2018-12-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: St. Antonius Hospital

Investigator Full Name: Valerie Monpellier

Investigator Title: MD PhD candidate

Keywords
Has Expanded Access No
Arm Group

Label: Body Contouring Surgery

Description: All patients who undergo BCS after bariatric surgery.

Acronym CONTOUR
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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