Bariatric SurgeryCONTOURNCT02552433
Complications in Body Contouring Surgery
An observational study of Bariatric Surgery and Body Contouring Surgery, run by St. Antonius Hospital at 3 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery, Body Contouring Surgery
- What is being tested?
- protein intake assessment and optimisation
- How many people
- 160 participants
- Where
- 3 sitesNetherlands
- Study dates
- Sep 2015to Sep 2019
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Rijnstate Hospital
Arnhem
Catharina Hospital
Eindhoven, North Brabant, 5623 EJ
Sint Antonius Hospital
Nieuwegein, Utrecht, 3430 EM
About this study
Official title: Complications in Post-bariatric Body Contouring Surgery; Prevalence With hands-on Treatment Regimen
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.
Read the 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.
- Conditions
- Bariatric Surgery, Body Contouring Surgery
- Being tested
- protein intake assessment and optimisation
- Keywords
- nutritional deficiencies, plastic surgery, post-bariatric, protein, skin surplus
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protein intake assessment and optimisationDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Body Contouring Surgery | All patients who undergo BCS after bariatric surgery. Receives: Dietary Supplement: protein intake assessment and optimisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
complication rate
wound related complication rate
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Catharina Ziekenhuis Eindhoven
- Responsible party
- Principal investigator, Valerie Monpellier, St. Antonius Hospital
- Investigators
- Aebele Mink van der Molen, MD/PhD, Principal investigator, Sint Antonius HospitalMaarten Hoogbergen, MD/PhD, Principal investigator, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552433
- Sponsor's protocol ID
- R15.035
- Acronym
- CONTOUR
- Status last verified
- Dec 2018
- First submitted
- 15 Sep 2015
- Last updated
- 6 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complications in Post-bariatric Body Contouring Surgery; Prevalence With hands-on Treatment Regimen
- ClinicalTrials.gov ID
- NCT02552433
- Acronym / sponsor ID
- CONTOUR / R15.035
- Conditions
- Bariatric Surgery, Body Contouring Surgery
- Keywords
- nutritional deficiencies, plastic surgery, post-bariatric, protein, skin surplus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Collaborators
- Catharina Ziekenhuis Eindhoven
- Study start
- Sep 2015
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 17 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Body Contouring Surgery | – | Dietary Supplement: protein intake assessment and optimisationAll patients who undergo BCS after bariatric surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| protein intake assessment and optimisation | Dietary supplement | Body Contouring Surgery |
Primary outcome
complication rate
Time frame: 30 days
wound related complication rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aebele Mink van der Molen, MD/PhD principal investigator
Sint Antonius Hospital
Maarten Hoogbergen, MD/PhD principal investigator
Catharina Ziekenhuis Eindhoven
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery and Body Contouring Surgery, run by St. Antonius Hospital at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complication rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2018.