Open studies

Full title: A placebo controlled randomised trial of intravenous lidocaine in accelerating gastrointestinal recovery after colorectal surgery

Summary: A common problem in about 40% of patients having bowel surgery is that their bowel takes longer than normal to start working again. In most patients the bowel will start working after surgery in 3- 4 days, but in some it takes a week or more. We call this delayed recovery of gut function. This delayed recovery causes nausea, vomiting, complete
constipation, tummy pain and tummy swelling (distension). As a result, patients cannot eat or drink until gut function returns, their recovery is slower and they have to stay longer in hospital. There is no immediate cure, and although it gets better on its own in most cases, it can take from 3-7 days to do so. During this time patients have to have a continuous intravenous drip and often insertion of a nasogastric tube to empty the stomach to reduce vomiting (most patients find this very unpleasant).

One of the common drugs used in hospitals is the local anaesthetic Lidocaine, used to “freeze” parts of the body, for example for minor skin operations or dental procedures. Recently lidocaine has been used intravenously (through the vein) as part of a general anaesthetic. It reduces pain and inflammation caused by surgery, and seems to help other aspects of recovery that may be important for return of gut function, for example reducing nausea and vomiting, and shortening the time from surgery to first bowel movement. However, previous studies were small and the true benefit of Intravenous (IV) lidocaine is uncertain. We hope to find out if giving IV Lidocaine improves recovery of gut function after colorectal surgery for NHS patients

Full title: The ANTHEM Feasibility Study : Is A Novel THErapeutic mammaplasty procedure a safe and effective surgical alternative to Mastectomy for treatment of breast cancer?

Summary: Breast conserving surgery (BCS) is the preferred treatment for many women with breast cancer. Standard techniques, however frequently result in poor cosmetic outcomes and mastectomy (removal of the breast) with or without immediate breast reconstruction is often recommended. Currently 40% of the 55,000 women diagnosed with breast cancer each year undergo a mastectomy but of these only 1 in 4 receive reconstruction.

Oncoplastic breast conservation surgery (OPBCS) describes a range of volume replacement (e.g local perforator flap LPF)) and volume displacement techniques (e.g Therapeutic mammaplasty (TM)) that may extend the boundaries of standard BCS and allow some women to avoid mastectomy and potentially improve their quality of life.

There is a need for high-quality research to determine whether OPBCS offers a safe and effective alternative to mastectomy but preliminary work is needed to ensure a future large-scale study is feasible, well-designed and addresses questions important to patients and the NHS.

The feasibility study will have 4 parts:
1. A national survey (a nested service evaluation) to understand current national practice of OPBCS
2. A pilot study to explore how many women are suitable for OPBCS as an alternative to mastectomy; choose to undergo the procedure and whether existing patient-reported outcome questionnaires measure outcomes important to patients undergoing different types of surgery accurately and can reliably be used in a future large study.
3. Interviews with patients to explore their views of different surgical options and the adequacy of questionnaires used to assess key patient-reported outcomes
4. Design of the future study

This study will be the first-step providing high-quality evidence to support the use of OPBCS as an alternative to mastectomy. It will promote choice, improving outcomes for patients, many of whom will be long-term breast cancer survivors.

Full title: UK Cohort study to Investigate the prevention of Parastomal Hernia

Summary: 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.

Full title: The PITSTOP Study: PIlonidal sinus Treatment: STudying the OPtions

Summary: We propose a prospective cohort study to determine the subtypes of pilonidal disease, to describe the various interventions, to engage with patients and to determine which outcomes they value and which interventions they prefer/do not prefer and to provide recommendations for further research.

Prior to the commencement of the cohort study there will be a survey circulated within the colorectal consultant surgeon network. This survey will seek to determine the methods of surgery currently employed in the field and the ways in which the surgeon learned this technique. The survey will also explore the factors affecting choice of treatment method in relation to disease presentation. Finally, it will seek to investigate the estimated mean recurrence rate for each surgeon.

The study will follow patients with symptomatic pilonidal sinus referred to each collaborating site, prospectively recording details of their pit / track anatomy, surgical management, medical events, health-related quality of life until six months after their operation.

It will then describe the combination of interventions currently in use and quantify clinical and patient-reported outcomes associated with each. It will also identify patient-specific disease features that might predict poor outcomes in each treatment group by risk-modelling methods.

It will then derive a case-mix adjusted estimate of the risks associated with common treatment options, using causal inference methods to provisionally rank the optimal management strategies among patients for whom more than one treatment is considered appropriate.

The study will then use nested mixed-methods case-studies to provide an overview of patient views and experiences of the treatment that they have chosen and received. This will this will also include the views of patients on which interventions they would rather avoid and which outcomes they most value in regards to their treatment options.

The study is predicted to reach a surgeon-based consensus on which subtypes of pilonidal disease may benefit from which treatment options. Additionally, the research is predicted to reach a surgeon and patient-based consensus on research priorities.

Full title: Rectal Surgery Evaluation Trial (RESET): Laparotomy vs Laparoscopy vs Robotic vs TaTME Rectal surgery matched parallel cohort trial for high surgical risk cancer patients, with mid- to low rectal cancer

Summary: Rectal Surgery Evaluation Trial (RESET): Laparotomy vs Laparoscopy vs Robotic vs TaTME Rectal surgery matched parallel cohort trial for high surgical risk cancer patients, with mid- to low rectal cancer

Full title: ROSSINI 2: A Phase III, multi-arm, multi-stage (MAMS) pragmatic, blinded (patient and outcome assessor) multicentre, randomised controlled trial (RCT) with an internal pilot, to evaluate the use of three in-theatre interventions, alone or in combination, to reduce SSI rates in patients undergoing abdominal surgery.

Summary: BACKGROUND: Surgical site infection (SSI) is a significant problem for patients and the health service, but is potentially preventable. Up to 25% of patients undergoing abdominal operations will develop an SSI. At an average cost of £3500 per SSI, it has been estimated that SSIs currently cost the NHS around £700 million per year, largely through prolonged postoperative inpatient stay and additional inpatient and outpatient treatment costs. Patients who develop SSIs have higher rates of pain and discomfort, with an increased risk of death following their operation.

AIM: The aim of ROSSINI 2 is to see whether three new in-theatre interventions, alone or in combination, reduce the rate of SSI.

METHODS: This multicentre, multi-arm, multi-stage, randomised clinical trial, will assess three separate in-theatre interventions used alone or in combination. The interventions include a skin preparation solution (2% alcoholic chlorhexadine skin prep) that is applied to the skin before starting surgery, a skin drape (Iodophor-impregnated incise drape) -a thin impregnated plastic sheet applied to the skin before making the incision and a sponge (gentamicin impregnated implant), which is an implant that contains antibiotics that is placed into the wound before closure. We will recruit 6613 patients from around 68 hospitals across the UK to go into the trial. The primary outcome measure is the rate of SSI at 30 days post-surgery. Numerous secondary outcomes will also be collected, including cost effectiveness of the interventions and impact on participants quality of life. Our findings will be published in international medical journals so that they can help patients globally.

Closed studies