Complications in Body Contouring Surgery

NCT02552433 | Unknown

• 1 other identifier: R15.035
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 3

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.

Conditions

Bariatric Surgery; Body Contouring Surgery

Keywords

nutritional deficiencies; plastic surgery; post-bariatric; protein; skin surplus

Outcome Measures

Primary Outcomes (1)

• complication rate

  wound related complication rate

  30 days

Study Arms (1)

Body Contouring Surgery

All patients who undergo BCS after bariatric surgery.

Dietary Supplement: protein intake assessment and optimisation

Interventions

protein intake assessment and optimisation DIETARY_SUPPLEMENT

Body Contouring Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Antonius Hospital: lead
• Catharina Ziekenhuis Eindhoven: collaborator

Study Sites (3)

Catharina Hospital

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

Sint Antonius Hospital

Nieuwegein, Utrecht, 3430 EM, Netherlands

Location

Rijnstate Hospital

Arnhem, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bloodsamples, asessing: * albumin * hemoglobin * vitamin D (25-hydroxy vitamin D) * ferritin * folic acid * vitamin B12

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Aebele Mink van der Molen, MD/PhD

  Sint Antonius Hospital

  PRINCIPAL INVESTIGATOR

• Maarten Hoogbergen, MD/PhD

  Catharina Ziekenhuis Eindhoven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD candidate

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: September 17, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: December 6, 2018

Record last verified: 2018-12

Locations

NL (3)