Complications in Body Contouring Surgery

Bariatric Surgery Clinical Trial

— CONTOUR  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02552433
• Other study ID #: R15.035
• Status: Enrolling by invitation
• Start date: September 2015
• Est. completion date: September 2019

Study information

• Verified date: December 2018
• Source: St. Antonius Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 160
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery
• Body Contouring Surgery

Intervention

Dietary Supplement:
• protein intake assessment and optimisation

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem
Netherlands	Catharina Hospital	Eindhoven	Noord-Brabant
Netherlands	Sint Antonius Hospital	Nieuwegein	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
St. Antonius Hospital	Catharina Ziekenhuis Eindhoven

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complication rate	wound related complication rate	30 days