StomaPhase 1LiSPANCT02090985
Lipomodelling for Symptomatic Peri-stomal Skin Contour Abnormalities: a Pilot and Feasibility Study
A Phase 1 study testing Lipomodelling of symptomatic peri-stomal skin contour abnormalities in people with Stoma, run by Western Sussex Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stoma
- What is being tested?
- Lipomodelling of symptomatic peri-stomal skin contour abnormalities
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2013to Jun 2015
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18 - 100 years old
- Patients who are able to give informed consent
- Patients who have had a stoma (colostomy, ileostomy or urostomy) for > 1 year
- Patients with a stoma that is likely to be permanent
- Patients with a stoma that is not due to be reversed within the following year (length of study)
- All patients with a stoma suffering with frequent soiling due to difficulty in stoma bag fitting will be assessed. If this is due to peri-stomal skin contour abnormalities they may be suitable for lipomodelling.
- Preoperative assessment will be based on clinical history, clinical examination and inspection of peri-stomal area prior to registering as a participant for the trial.
Who cannot join
- Patients unable to give informed consent or refuse to participate in this study
- Patients who have had their stoma for less than 1 year
- Patients with a temporary stoma that is due o be reversed within a year
- Patients who have a stoma on which the stoma bag fits securely and is not leaking
- Patients with allergy to any medication used in local infiltration
- Patients with an underlying medical condition that excludes them from the study (e.g. risk of increase in bleeding such as patients on warfarin.)
- Patients with evidence of underlying infection.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Worthing Hospital
Worthing, East Sussex, BN11 2DH
Anna Z Conway, MBBS, BSc, MRCS
Riccardo Bonomi, MS
About this study
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.
Read more
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.
Read the detailed description
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
- Conditions
- Stoma
- Being tested
- Lipomodelling of symptomatic peri-stomal skin contour abnormalities
- Keywords
- Stoma, Peri-stomal, Lipomodelling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipomodelling of symptomatic peri-stomal skin contour abnormalitiesProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Lipomodelling | Experimental | Lipomodelling of peri-stomal skin contour abnormalities Receives: Procedure: Lipomodelling of symptomatic peri-stomal skin contour abnormalities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Requirement for the use of extra stomal appliances
Extra appliances are usually required by patients who have stomas that constantly leak because the bag does not fit properly. After undergoing lipomodelling around the stoma the aim is for the stoma bag to fit more securely and less stoma appliances will be needed.
Measured: Change is being assessed from pre and post procedure to end of follow-up at 12 months
Quality of life
If the stoma bag is fitting more securely then an improvement in the patients quality of life is anticipated.
Measured: Participants will be followed for 12 months following the procedure
Secondary outcomes (2)
Frequency of soiling in 24 hours.
If the stoma bag fits more securely then there should be less soiling and leakage.
Measured: Participants will be followed for 12 months following the procedure
Cost analysis
If less extra stoma appliances are required then this may save money.
Measured: Participants will be followed for 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startSep 2013
- Primary completionDec 2014 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StomaStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Sussex Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bonomi, Principal investigator, Western Sussex Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02090985
- Sponsor's protocol ID
- 1543/WSHT/2013
- Other IDs
- 13/LO/0806
- Acronym
- LiSPA
- Status last verified
- Mar 2014
- First submitted
- 11 Nov 2013
- Last updated
- 19 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02090985
- Acronym / sponsor ID
- LiSPA / 1543/WSHT/2013
- Conditions
- Stoma
- Keywords
- Stoma, Peri-stomal, Lipomodelling
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Western Sussex Hospitals NHS TrustUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 19 Mar 2014 (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.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lipomodelling | Experimental | Procedure: Lipomodelling of symptomatic peri-stomal skin contour abnormalitiesLipomodelling of peri-stomal skin contour abnormalities |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged 18 - 100 years old
- Patients who are able to give informed consent
- Patients who have had a stoma (colostomy, ileostomy or urostomy) for > 1 year
- Patients with a stoma that is likely to be permanent
- Patients with a stoma that is not due to be reversed within the following year (length of study)
Key exclusion criteria (7 listed)
- Patients unable to give informed consent or refuse to participate in this study
- Patients who have had their stoma for less than 1 year
- Patients with a temporary stoma that is due o be reversed within a year
- Patients who have a stoma on which the stoma bag fits securely and is not leaking
- Patients with allergy to any medication used in local infiltration
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 |
|---|---|---|
| Lipomodelling of symptomatic peri-stomal skin contour abnormalities | Procedure or surgery | Lipomodelling |
Primary outcome
Requirement for the use of extra stomal appliances
Time frame: Change is being assessed from pre and post procedure to end of follow-up at 12 months
Extra appliances are usually required by patients who have stomas that constantly leak because the bag does not fit properly. After undergoing lipomodelling around the stoma the aim is for the stoma bag to fit more securely and less stoma appliances will be needed.
Quality of life
Time frame: Participants will be followed for 12 months following the procedure
If the stoma bag is fitting more securely then an improvement in the patients quality of life is anticipated.
2 secondary outcomes
Frequency of soiling in 24 hours.
Time frame: Participants will be followed for 12 months following the procedure
Cost analysis
Time frame: Participants will be followed for 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2014.
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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.
Bonomi principal investigator
Western Sussex Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lipomodelling of symptomatic peri-stomal skin contour abnormalities in people with Stoma, run by Western Sussex Hospitals NHS Trust at 1 site in United Kingdom.
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 7 inclusion and 7 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 19 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Anna Z Conway, MBBS (+44 7957 887394, annaconway@doctors.org.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Requirement for the use of extra stomal appliances (time frame: Change is being assessed from pre and post procedure to end of follow-up at 12 months). The study lists 2 primary outcomes in all. 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 19 Mar 2014.