Stoma Clinical Trial
Official title:
The Use of Lipomodelling Induced Skin Rejuvenation for the Management of Symptomatic Peri-stomal Skin Contour Abnormalities to Improve Quality of Life. A Pilot and Feasibility Study.
In this study a technique called 'lipomodelling' is being studied to find out if it is
beneficial around the stoma site in patients who have difficulty with securing their stoma
bags which may lead to leakage and frequent soiling which we believe reduces quality of life.
Patients with colostomy (stoma formed by bringing large bowel to the surface of the abdomen),
ileostomy (small bowel) or a urostomy (urinary tract) will be recruited into this study.
Lipomodelling is a technique that is commonly used elsewhere in the body but to our knowledge
has not been used for this purpose. This study is a pilot study that may lead to further
research in this area.
Lipomodelling means taking some of your own fat that lies just beneath the surface of the
skin and transferring it to another part of your body. The fat is removed by suction
(liposuction), normally from your thighs or abdomen. In order to use the most important part
of the fat, it is then put into a machine called a centrifuge. This spins the fat so that it
splits up into three different sections. The most important section is then separated and
injected in very small quantities into the required areas around your stoma. It is thought to
have cells that encourage rejuvenation as well as helping to fill the area injected.
Peri-stomal means the area around the stoma itself, this includes skin and underlying tissue,
which will be fat and scar tissue. After any operation there will be scarring that takes some
time to fully develop. Usually after a year the scar tissue will be fully formed. The scar
tissue may cause the skin around the stoma to be irregular. This is described as contouring
of the skin.
The aim of this study is to see if lipomodelling can improve your quality of life by reducing
the frequency of changing your stoma bag, reduce leakage and the need for extra-stomal
appliances to try and help the stoma bag fit to your body securely.
OBJECTIVE Symptomatic skin contour abnormalities often lead to frequent soiling and
difficulty in stoma bag fitting. The objective of this study is to evaluate the effectiveness
of peri-stomal lipomodelling in reducing the number of stoma bag changes in 24 hours and
overall quality of life in this patient group.
METHODS Patients will be identified by the stoma care nurses or digestive diseases or urology
clinics. They will be assessed for suitability for the study. If suitable, informed consent
will be taken. Quality of life questionnaires will be completed by the participant prior to
the procedure and at several intervals following the procedure. Follow-up will end at 1 year
post procedure.
BACKGROUND Intestinal stoma formation for faecal diversion or defunctioning the bowel, is a
commonly established procedure in colorectal surgical practice [1-6]. It can be performed by
open as well by laparoscopic approach. However, placement of an ileoostomy or colostomy on
the abdominal wall skin surface is associated with many skin complications like skin
ulceration arising from excoriation and scarring, skin retraction leading to peri-stomal skin
dimples and irregular margins [7-13]. This may result in the stoma appliance not fitting
properly to the skin leading to frequent soiling of the skin and clothes. Soiling can cause a
significant impact on the patients quality of life [14]. Soiling of the skin and clothes
requires frequent change of stoma appliances, use of various fittings around stoma and under
stoma bag to try to avoid soiling. Consequently, the cost of stoma management increases due
to extra stoma care by stoma nurse and additional use of stoma appliances [15]. Stomas can be
resited in order to try and improve the situation for the patient. This may require a major
operation including a laparotomy (opening the abdomen). Due to previous surgery there is
likely to be scar tissue inside the abdomen which can make this operation difficult and
hazardous as there is a risk of damaging the bowel.
This study aims to identify whether it is possible to reduce soiling by improving the area
around the stoma so that the stoma bag can fit properly through lipomodelling. A technique
that can be performed as a day case, under local anaesthetic and without a major operation.
Lipomodelling, also known as autogenous fat transfer or fat transplantation, is used to
correct skin deformities elsewhere (such as breast) and so may be useful in correcting
peri-stomal skin deformities. We hypothesis that peri-stomal lipomodelling should improve the
peri-stomal skin contour abnormality and therefore improve the fitting of the stoma bag to
the skin so reduce soiling with the aim of reducing number of stoma bag changes in 24 hours
and thereby improving quality of life. This technique has been applied to correct skin
defects in patients undergoing breast surgery, limbs surgery, buttocks and genitals [16-19].
Recent studies demonstrated that adipose tissue harvested during lipomodelling is a very rich
source of regenerative cells called adipose derived stem cells (ADSC) [20]. ADSCs are capable
of self- renewal and also secrete growth factors [21]. ADSCs have been reported to enhance
elasticity of scar tissue and promote healing in patients undergoing radiotherapy for breast
cancer, and in complex Crohn's fistulae [22-26]. In the peri-stomal area hopefully the
lipomodelling will not only fill the defect, but also improve the elasticity of the scar
tissue softening the area.
The objective of this prospective observational pilot study is to evaluate the effectiveness
of peri-stomal lipomodelling in correcting the peri-stomal skin contour defects aiming to
reduce the frequent of leakage and soiling, aiming to improve overall quality of life.
Sample size: 20 patients for this phase 1 pilot study
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