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Complications in Body Contouring Surgery (CONTOUR)

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ClinicalTrials.gov Identifier: NCT02552433
Recruitment Status : Enrolling by invitation
First Posted : September 17, 2015
Last Update Posted : December 6, 2018
Sponsor:
Collaborator:
Catharina Ziekenhuis Eindhoven
Information provided by (Responsible Party):
Valerie Monpellier, 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.

Condition or disease Intervention/treatment
Bariatric Surgery Body Contouring Surgery Dietary Supplement: protein intake assessment and optimisation

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 : Observational [Patient Registry]
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: Complications in Post-bariatric Body Contouring Surgery; Prevalence With hands-on Treatment Regimen
Study Start Date : September 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Group/Cohort Intervention/treatment
Body Contouring Surgery
All patients who undergo BCS after bariatric surgery.
Dietary Supplement: protein intake assessment and optimisation



Primary Outcome Measures :
  1. complication rate [ Time Frame: 30 days ]
    wound related complication rate


Biospecimen Retention:   Samples Without DNA

Bloodsamples, asessing:

  • albumin
  • hemoglobin
  • vitamin D (25-hydroxy vitamin D)
  • ferritin
  • folic acid
  • vitamin B12


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02552433


Locations
Netherlands
Catharina Hospital
Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
Sint Antonius Hospital
Nieuwegein, Utrecht, Netherlands, 3430 EM
Rijnstate Hospital
Arnhem, Netherlands
Sponsors and Collaborators
St. Antonius Hospital
Catharina Ziekenhuis Eindhoven
Investigators
Principal Investigator: Aebele Mink van der Molen, MD/PhD Sint Antonius Hospital
Principal Investigator: Maarten Hoogbergen, MD/PhD Catharina Ziekenhuis Eindhoven

Responsible Party: Valerie Monpellier, MD PhD candidate, St. Antonius Hospital
ClinicalTrials.gov Identifier: NCT02552433     History of Changes
Other Study ID Numbers: R15.035
First Posted: September 17, 2015    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018

Keywords provided by Valerie Monpellier, St. Antonius Hospital:
nutritional deficiencies
plastic surgery
post-bariatric
protein
skin surplus