Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02174458 |
| Other study ID # |
BC_QoL_EK_311/13 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
June 24, 2014 |
| Last updated |
March 17, 2015 |
| Start date |
January 2014 |
| Est. completion date |
June 2014 |
Study information
| Verified date |
March 2015 |
| Source |
University Hospital, Basel, Switzerland |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Switzerland: Ethikkommission |
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Body contouring (BC) surgery after major weight loss (MWL) requires extensive and multiple
procedures. Yet, there are inconsistent data regarding the outcome after BC procedures. The
aim of this study is to investigate the outcome from patients who elect to have BC
procedures after MWL treated at a single metropolitan tertiary referral center.
Description:
Background The obesity epidemic worldwide continues to worsen, with rates in Europe and
North America estimated at about 20-30% of the adult population.(Vico et al., 2010) It is
defined as a body mass index (BMI) above 30, and morbid obesity as a BMI above
40kgm-2.(Strauch et al., 2006; Vico et al., 2010) As a consequence, there is an explosive
growth of obesity-associated comorbidities, associated with high healthcare costs.(Reiffel
et al., 2013) One of the few consistent means of achieving a significant weight-loss in
morbidly obese patients is bariatric surgery (BS).(Buchwald et al., 2004; Maggard et al.,
2005) Shermak et al. defined massive weight loss (MWL) as 50% or greater loss of excess
weight.(Shermak et al., 2006) Next to the amelioration of the medical comorbidities
associated with obesity, patients also benefit from improvement in their psychosocial
functioning, personal health perceptions and health-related quality of life.(Karlsson et
al., 1998; Karlsson et al., 2007; Sarwer et al., 2008) A major drawback after BS is the
persistence of large quantities of excess and inelastic skin and subcutaneous tissue. Thus,
patients often experience skin irritations, mycotic infections and secondary self-imaging
problems.(Reiffel et al., 2013; Vico et al., 2010) Body contouring (BC) surgery, usually
excisional, includes (circumferential) abdominoplasty, breast reduction, panniculectomy,
brachioplasty, and thigh lift. It removes the excess tissue which remains after massive
weight loss and consecutively leads to a significant improvement in self-image and
self-esteem, as well as mobility, overall daily functioning and hygiene.(Larsen et al.,
2007; Song et al., 2006) These procedures are usually multiple and extensive. Thus,
combining and reducing the number of such procedures while obtaining optimal results would
be most beneficial to both the surgeon and the patient.(Ellabban and Hart, 2004; Hallock and
Altobelli, 1985) For patients who seek BS, quality of life is an important issue. In a
recent study by Modarressi et al. it has been shown that Roux-en-Y gastric bypass (RYGBP)
improves the health-related quality of life (HRQoL). Furthermore, it was shown that HRQoL is
directly related to weight loss and BC procedures further improves HRQoL in comparison to
RYGBP alone, as evidenced by the Moorehead-Ardelt questionnaire.(Modarressi et al., 2013;
Oria and Moorehead, 1998) Nevertheless, there is an urgent need to develop specific and
well-constructed patient reported outcome (PRO) instruments in order to obtain reliable
information regarding QoL and patient satisfaction following BC surgery in MWL
patients.(Jabir, 2013)
Clinical Data In the literature there are some inconsistent data regarding QoL scales after
BC procedures.(Singh et al., 2012) Problems after MWL with excessive skin folds compromises
body image and may negatively impact the physical and mental components of QoL.(Mitchell et
al., 2008) Thus, theoretically, after removal of skin excess, the QoL scales should improve
after BC procedures. Indeed, several studies have demonstrated improvements in QoL
associated with BC surgery.(Coriddi et al., 2011; Pecori et al., 2007; Song et al., 2006;
van der Beek et al., 2010) However, in a recent study by Singh et al., scales comprising the
mental component were lower in the group of patients who received BC procedures, indicating
impaired QoL.(Singh et al., 2012) Of those, role-emotional and social functioning were
significantly lower than both the control and the post-bariatric surgery group, showing that
those patients who elected to have BC procedures suffer from worsening inhibited social
interactions.(Singh et al., 2012) It might be arguable that patients in the post-bariatric
surgery group who elected not to undergo BC chose so because their QoL was already
high.(Singh et al., 2012) Thus, counseling and education prior to plastic surgery is
extremely important to ensure appropriate expectations for the patient in regard to scarring
and the realistic scope that can be accomplished by surgery.(Singh et al., 2012) QoL,
especially in women aged between 35 to 64 years old, is the most affected domain in patients
with BMI > 40kg/m2.(Larsson et al., 2002) This dissatisfaction motivates different
behaviours, including exercise, weight loss and cosmetic surgery.(Sarwer et al., 2008) Thus,
despite obesity is more prevalent in men, it might explain partially why women more
frequently seek bariatric surgery.(Modarressi et al., 2013) Following BS, patients are
initially enthusiastic to see cure of their diabetes, decreased pain in their joints and
weight loss.(Colwell, 2010) Nevertheless, the skin does not contract with the volume
loss.(Colwell, 2010) As soon as the weight has been stable for at least 6 months, plastic
surgical evaluation seems to be appropriate.(Colwell, 2010) In general, the lower the BMI at
the time of BC surgery, the better the result.(Langer et al., 2011) Usually, condouting
procedures are preserved for those patients who attain a BMI less than or equal to
35.(Arthurs et al., 2007) To date, little is known about the frequency and proportions of
patients who undergo BS and consequently receive BC surgery. Reasons for not undergoing body
contouring procedures can be the lack of awareness regarding options and expense.(Reiffel et
al., 2013) Documentation of functional problems, such as rashes, sexual dysfunction and
difficulty with exercise are important in attempting to obtain insurance coverage for at
least part of their surgery.(Arthurs et al., 2007) Panniculectomy, defined as removal of
excess skin and fat in the abdomen without umbilical transpostion, is the surgical procedure
most likely to be covered by insurance.
Usually, truncal deformity is the most common presenting complaint of MWL patients, and the
procedure of choice is a lower body lift.(Colwell, 2010) It is crucial to focus
postoperatively on patient safety prioritizing in seroma prevention and deep vein thrombosis
(DVT) prophylaxis. Reported complication rates postoperative range between 17-50% including
wound-healing problems, haematoma, infection, necrosis or pulmonary embolism.(Vico et al.,
2010) Furthermore, many of these patients have psychiatric problems, and thus counseling,
especially in the perioperative period is extremely important.(Langer et al., 2011) The
number of procedures that can safely be performed in one sitting depends on the patient's
anatomy, the surgeon, the surgical facility and overall medical health.(Arthurs et al.,
2007) The patient's BMI should be normal or slightly overweight. Otherwise, staging the
procedures into two or more surgeries separated by 3-6 months is suggested.(Arthurs et al.,
2007) Ideally, the operative time should be kept under six hours or below to minimize
complications.(Langer et al., 2011) Obviously, if vectors of pull at surgery are in opposite
directions, such as in an upper body lift and a belt lipectomy/lower body lift, these
procedures should be performed separately.(Langer et al., 2011) In a study by Ellabban et
al., 14 patients were evaluated who underwent BC operations using combined abdominoplasty
and medial thigh reduction. The authors concluded that combined abdominoplasty with vertical
medial thigh reduction is effective in correcting aesthetic and physical problems after
massive weight reduction with an excellent predictable outcome.(Ellabban and Hart, 2004)
Also, combined brachioplasty, thoracoplasty, and mammoplasty has proven to be safe,
effective, and beneficial for both the surgeon and patient.(Hallock and Altobelli, 1985) In
order to establish an evidence base to support the idea that BC is as much (or even more) a
functional procedure as it is cosmetic, a flurry of studies assessing QoL and patient
satisfaction following BC surgery has been resulted.(Jabir, 2013) The method of choice to
assess QoL and patient satisfaction is to use patient specific psychometrically validated
PRO measures.(Jabir, 2013) To date, none of the measures have been specifically developed
for BC surgery patients. Instead, there is an urgent need to develop specific and well-
constructed PRO instruments in order to obtain reliable information regarding QoL and
patient satisfaction after BC surgery in MWL patients.(Jabir, 2013)
STUDY OBJECTIVES The main objective of this research is to analyse QoL and patient
satisfaction after BC surgery in MWL male and female patients.
We hypothesize that >80% of the patients have a total score of +2.25 to +3 ("much better")
or +0.75 to +2 ("better") in the Moorehead-Ardelt questionnaire. 66 patients of equal
distribution and demographic characteristics after bariatric surgery but no secondary
reconstructive procedure will serve as a control group.
The associated research questions are as follows:
What is the outcome in patients after BC surgery and MWL concerning:
Hypotheses:
Primary outcome:
After a mean follow-up of 8.9±3.5 years after BC surgery we hypothesize that >90% of the 66
patients will answer the survey. Based on the literature(Modarressi et al., 2013), we expect
that >80% of the patients have a total score of +2.25 to +3 ("much better") or +0.75 to +2
("better") in the Moorehead-Ardelt questionnaire.
