1406944 / Video rate blood flow imaging for reconstructive plastic surgery

Video rate blood flow imaging for reconstructive plastic surgery (Study due to close 02/03/2018)

1501035 / DCIS

The LORIS Trial aims to establish whether patients with newly diagnosed low risk DCIS can safely avoid surgery without detriment to their wellbeing (psychological and physical) and whether those patients who do require surgery can be identified by pathological and radiological means.

LORIS is a phase III, multicentre, 2 arm study, with a built in 2 year feasibility phase, in women confirmed by Central Histopathology Review to have low risk DCIS. Comprehensive site training will be complimented by a patient friendly DVD designed to ensure consistent and appropriate use of terminology. Patients will be randomised between standard surgery and active monitoring with annual mammography.  Follow-up will be for a minimum of 10 years. (Study due to close 05/06/2020)

1504083 / MAMMO-50

The Government`s Cancer Reform Strategy recommends breast cancer patients be supported in self-care and have personalised risk-adjusted follow-up to meet their needs. As young age is a strong predictor of invasive and non-invasive “second” breast cancer (i.e. recurrence on treated side or new cancer in opposite breast), current NICE 2009 guidance recommends patients diagnosed up to 50 years have mammograms annually. For those patients aged 50 or older at diagnosis, there is no clear evidence or consensus amongst specialists on risk-factors to advise the optimum frequency or duration of follow-up mammograms.

Type of breast surgery (mastectomy or conservation) does not affect long term survival. However, 3 years after diagnosis, second breast cancers are found less frequently by mammography in mastectomy patients than those patients who have had conservation surgery.  Early detection of second cancers or metastasis is more likely to occur via patient self-examination between mammograms than by specialist clinic visit. A patient’s ability to self-check and report concerns could be improved by alternative follow-up regimens including questionnaires and/or contact with nurses GPs, radiographers or internet access.  There have been no randomised controlled trials in this setting.

In order to provide sound evidence for future management, this clinical trial aims to establish if patients aged 50 years or over can be identified, who require less frequent mammographic surveillance whilst investigating alternative methods of follow-up. (Study due to close 31/03/2019)

1612346 / ThyVoice

ThyVoice – a national observational cohort study of voice outcome after thyroid surgery (Study due to close 01/05/2018)

1705430 / UK Cohort study to Investigate the prevention of Parastomal Hernia

During abdominal surgery, it is sometimes necessary to create a stoma to divert faeces from the bowel into an external pouch or bag. Unfortunately, the formation of the stoma can be associated with future complications, including the risk of developing a parastomal hernia (PSH). A PSH is an incisional hernia, immediately adjacent and related to the stoma, that occurs when the fascia in the abdominal wall splits. Contents of the abdomen, e.g. fatty tissue or intestine, can be forced through the split in the fascia causing a bulge in the skin.

PSH are relatively common and affect approximately 40% of patients within 2 years of their bowel surgery.

Complications of PSH can be severe and are known to negatively influence patients’ quality of life. Specifically, PSH can make it difficult to attach stoma bags which can cause the bag contents to leak and smell, irritate the surrounding skin and make patients anxious and avoid social situations. PSH can also cause pain and serious problems, e.g. bowel obstruction, which need emergency treatment in hospital. PSH are difficult to manage and in most cases treatment involves specialist stoma care with expensive appliances. In some cases, a surgeon may reoperate to repair the hernia but additional surgery is risky and recurrence of a hernia is not uncommon. Therefore, it is very important to prevent a PSH forming in the first place.

Both patient and surgical factors are believed to influence the development of PSH. Of the surgical factors, the size and shape of the incision in the body wall, the use of mesh when the stoma is formed and, if mesh is used, exactly how it is used, have all been described as potentially important considerations. However, the way in which surgeons create stomata is very varied and research is needed to investigate whether these factors influence the risk of developing a PSH. This is the aim of the CIPHER study. (Study due to close 30/11/2019)

1707466 / The PUrE RCTPercutaneous Nephrolithotomy (PNL), Flexible Ureterorenoscopy (FURS) and Extracorporeal Lithotripsy (ESWL) for lower pole Kidney stones 

Renal tract stone disease is very common and mainly affects adults of working age and the incidence has been increasing.  Approximately 50% of renal stones will cause symptoms and up to 26% will require an active intervention.  Currently the NHS has three treatment options for lower pole kidney stones, extracorporeal shock wave lithotripsy (ESWL), percutaneous nephrolithotomy (PNL) and flexible ureterorenoscopy with laser lithotripsy (FURS).  This UK wide multi-centre RCT (with internal feasibility) will determine for lower pole stones whether flexible ureterorenoscopy with laser lithotripsy result in better quality of life (EQ-5D) than ESWL or PNL (chosen according to stone size). (Study due to close 02/07/2019)

1805630 / The impact of postoperative Packing of Perianal Abscess Cavities: a multicentre randomised controlled trial

A perianal abscess is an infection close to the back passage (anus). It occurs in thousands of UK patients every year. Standard treatment is a small operation under general anaesthetic when an opening is made in the abscess to let out the infection. The usual treatment is then to place a dressing into the wound (packing). The wound pack is changed every one to two days. Packing has traditionally been used as it is thought to aid healing. However, packing wounds is painful and a small study has suggested that packing may not help wound healing. We are conducting a study (Packing of Perianal Abscess Cavities, PPAC2) on patients after drainage of a perianal abscess.

This will answer the question whether simple dressings on the wound surface are better than traditional packing into the wound. Over a 6-months period, we will assess patients’ discomfort after surgery, time taken to return to normal activities and how patients’ quality of life is affected. We will also check that the new treatment (simple dressings rather than packing) does not increase the risk of complications from the abscess. We will check healing rates and recurrent infections in each patient.

Patients will be invited to participate in PPAC2 after abscess drainage. A computer will randomly assign patients (like tossing a coin) to the new treatment of simple wound dressings or the traditional treatment (wound packing). Patients will keep a diary of dressing or packing changes, discomfort they feel after leaving hospital and return to normal activities. Patients will be seen in clinic to check healing.

Results will be shared by publication in medical journals, and feedback to doctors, community nurses and organisations such as National Institute Clinical Evidence. The team undertaking the study is composed of experts with a track record of research in this field. (Study due to close 03/05/2019)

1806642 / Multi-centre, observational, post-market, real world registry to assess outcomes of patients treated with Altura TM endograft system for endovascular abdominal aortic aneurysm repair.

Multi-centre, observational, post-market, real world registry to assess outcomes of patients treated with Altura TM endograft system for endovascular abdominal aortic aneurysm repair. (Study due to close 30/11/2019)

1901744 / CLOSurE of Ileostomy Timing Study

A defunctioning ileostomy is often formed during rectal cancer surgery to reduce potentially fatal sequelae of anastomotic leak. Many patients suffer poor bowel function, i.e. low anterior resection syndrome (LARS), once their ileostomy is closed and delay to closure can increase incidence of LARS and significantly reduce quality of life. Despite this, time to closure of ileostomy is not subject to national targets within the NHS and delay to closure exceeds 18 months in a third of patients with a temporary ileostomy.

Clinical factors, surgeon and patient preference or service pressures may all impact time to closure yet to date no study has investigated this. The aim of this UK-wide study is to assess time to ileostomy closure and identify reasons for delays. Results will inform consensus guidelines on optimum treatment pathways following temporary ileostomy formation. (Study due to close 01/10/2018)

1901744 / CLOSurE of Ileostomy Timing Study

A defunctioning ileostomy is often formed during rectal cancer surgery to reduce potentially fatal sequelae of anastomotic leak. Many patients suffer poor bowel function, i.e. low anterior resection syndrome (LARS), once their ileostomy is closed and delay to closure can increase incidence of LARS and significantly reduce quality of life.

Despite this, time to closure of ileostomy is not subject to national targets within the NHS and delay to closure exceeds 18 months in a third of patients with a temporary ileostomy.
Clinical factors, surgeon and patient preference or service pressures may all impact time to closure yet to date no study has investigated this.

The aim of this UK-wide study is to assess time to ileostomy closure and identify reasons for delays. Results will inform consensus guidelines on optimum treatment pathways following temporary ileostomy formation. (Study due to close 01/10/2018)