Lipomodelling for Symptomatic Peri-stomal Skin Contour Abnormalities: a Pilot and Feasibility Study

NCT02090985 | Unknown Phase 1 DMC

• 2 other identifiers: 1543/WSHT/201313/LO/0806
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stoma

Keywords

Stoma; Peri-stomal; Lipomodelling

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Participants will be followed for 12 months following the procedure

Secondary Outcomes (2)

• Frequency of soiling in 24 hours.

  Participants will be followed for 12 months following the procedure

• Cost analysis

  Participants will be followed for 12 months

Study Arms (1)

Lipomodelling

EXPERIMENTAL

Lipomodelling of peri-stomal skin contour abnormalities

Procedure: Lipomodelling of symptomatic peri-stomal skin contour abnormalities

Interventions

Lipomodelling of symptomatic peri-stomal skin contour abnormalities PROCEDURE

Lipomodelling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western Sussex Hospitals NHS Trust: lead

Study Sites (1)

Worthing Hospital

Worthing, East Sussex, BN11 2DH, United Kingdom

RECRUITING

Study Officials

• Bonomi

  Western Sussex Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Z Conway, MBBS

CONTACT

+44 7957 887394; annaconway@doctors.org.uk

Riccardo Bonomi, MS

CONTACT

+44 1903 205111; riccardo.bonomi@wsht.nhs.uk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2013
• First Posted: March 19, 2014
• Study Start: September 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: June 1, 2015
• Last Updated: March 19, 2014

Record last verified: 2014-03

Locations

GB (1)