To describe the wound related complication rate in post-bariatric body contouring surgery patients who are treated according to a new guideline and assess the factors associated with a higher complication rate.
ID
Source
Brief title
Condition
- Ancillary infectious topics
- Appetite and general nutritional disorders
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Wound related complications within 30 days after body contouring surgery.
Secondary outcome
Demographics, weight history, bariatric surgery, relevant history, consequences
of excess skin, nutritional status, body contouring surgery and other
complications.
Background summary
There is a growing population of patients who successfully undergo bariatric
surgery and are then eligible for body contouring surgery (BCS). BCS improves
patient well-being and quality of life, also it seems to prevent long term
weight regain after bariatric surgery. However body contouring procedures have
a high risk for wound related complications. Literature assessing the factors
that influence the complication rate is sparse and inconclusive. The poor
nutritional status, which frequently occurs after bariatric surgery, has been
linked to the high complication rate. However improving nutritional status was
never part of standard treatment in previous research.
Study objective
To describe the wound related complication rate in post-bariatric body
contouring surgery patients who are treated according to a new guideline and
assess the factors associated with a higher complication rate.
Study design
Prospective descriptive study.
Study burden and risks
The burden of participation is one extra hospital visit with consultation of
dietician and an extra blood sample which is drawn during surgery.
koekoekslaan 1
Nieuwegein 3435CM
NL
koekoekslaan 1
Nieuwegein 3435CM
NL
Listed location countries
Age
Inclusion criteria
* post-bariatric patient
* undergoing body contouring surgery because of skin surplus
* contouring in one of the following regions:
abdomen
mammae
legs
arms
upper body
lower body
Exclusion criteria
* Body Mass Index (BMI) is higher than 34.9 kg/m2
* weight not stable 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-(GFR<30) or liver failure
- bariatric surgery other than Laparoscopic Adjustable Gastric Band, (laparoscopic) Roux-en-Y gastric bypass or (laparoscopic) gastric sleeve
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL53259.100.15 |